To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

July 15, 2013 updated by: Bayer

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment.

The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.

Study Overview

Detailed Description

Safety issues are addressed in the Adverse Events section.

Study Type

Interventional

Enrollment (Actual)

409

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quebec, Canada, G3K 2P8
        • Alpha Recherche Clinique
    • British Columbia
      • Langley, British Columbia, Canada, V3A 4H9
        • Glover Medical Clinic
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4Z9
        • Maritimes Research Center
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • White Hills Medical Clinic
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 5R3
        • MSHJ Research Associates
    • Ontario
      • Corunna, Ontario, Canada, N0N 1G0
        • Corunna Medical Research Centre
      • Downsview, Ontario, Canada, M3J 1N2
        • Office of Dr. Ivor Teitelbaum, MD
      • Hamilton, Ontario, Canada, L8M 1K7
        • Hamilton Medical Research Group
      • Hamilton, Ontario, Canada, L8L 5G8
        • Office of Dr. Allen S. Greenspoon, MD
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Office of Dr. Sami Henein, MD
      • Ottawa, Ontario, Canada, K1H 7W9
        • Ottawa Hospital-Riverside Campus
      • Sarnia, Ontario, Canada, N7T 4X3
        • London Road Diagnostic Centre
      • Toronto, Ontario, Canada, M9W 4L6
        • Manna Research
      • Toronto, Ontario, Canada, M4S 1Y2
        • Prime Health Research
      • Woodstock, Ontario, Canada, N4S 5P5
        • Devonshire Clinical Research, Inc.
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 5Y9
        • Island Clinical Trials
    • Quebec
      • Drummondville, Quebec, Canada, J2B 7T1
        • Rhodin Recherche Clinique
      • Mirabel, Quebec, Canada, J7J 1L2
        • Omnispec Recherche Clinique Inc.
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Kells Medical Research Group, Inc.
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Dynamik Clinical Research Group
      • Shawinigan, Quebec, Canada, G9N 2H6
        • Clinique de Gynecologie
      • Ste-Foy, Quebec, Canada, G1V 4X7
        • Clinique Médicale des Campus
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 3X1
        • Regina Medical Centre
      • Saskatoon, Saskatchewan, Canada, S7H 5M3
        • Acadia Medical Centre
      • Saskatoon, Saskatchewan, Canada, S7K 7H9
        • Lenore Center Medical Clinic
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Precision Trials, LLC
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
    • California
      • Encinitas, California, United States, 92024
        • Pacific Coast Research Center Inc.
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • Santa Monica, California, United States, 90404
        • Blue Hill Medical Group
    • Colorado
      • Denver, Colorado, United States, 80218
        • Downtown Women's Healthcare
      • Denver, Colorado, United States, 80206
        • Cherry Creek Family Practice
      • Littleton, Colorado, United States, 80127
        • Altitude Family Medicine, PC
    • Florida
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
      • Jacksonville, Florida, United States, 32207
        • University of Florida College of Medicine
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Soapstone Center for Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83712
        • The Women's Clinic
      • Boise, Idaho, United States, 83702
        • Women's Health Associates
      • Idaho Falls, Idaho, United States, 83406
        • Rosemark Clinical Research
    • Indiana
      • Fishers, Indiana, United States, 46037
        • Internal Medicine and Pediatrics
      • Indianapolis, Indiana, United States, 46217
        • First Care Family Medicine
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Womens Heatlh Research, Inc.
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management, LLC
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • PPS Clinical Research, LLC
      • St. Louis, Missouri, United States, 63141
        • New Ballas OB-GYN, Inc.
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Women's Clinic of Lincoln, PC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Office of Dr. R. Garn Mabey, MD
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Gynecologic Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Associates in OB-GYN, Inc.
      • Columbus, Ohio, United States, 43213
        • Columbus Center for Women's Health Research
    • Oregon
      • Portland, Oregon, United States, 97239-3011
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research of Philadelphia, LLC
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
      • Memphis, Tennessee, United States, 38120
        • Adam Patterson OB-GYN
    • Texas
      • Houston, Texas, United States, 77054
        • The Woman's Hospital of Texas
    • Washington
      • Spokane, Washington, United States, 99207
        • North Spokane Women's Health Research
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • University of Wisconsin - La Crosse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Signed and dated informed consent
  • Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1
  • Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction)
  • Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS.
  • Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator

Exclusion Criteria:

  • Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment)
  • Body mass index (BMI) >32 kg/m2
  • Hypersensitivity to any of the study drug ingredients
  • Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules
  • Safety relevant laboratory values, provided by the central laboratory, outside inclusion range before start of treatment
  • Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise)
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Any disease or condition that may worsen under hormonal treatment
  • Undiagnosed abnormal genital bleeding
  • Abuse of alcohol, drugs, or medicines (eg, laxatives)
  • Other contraceptive methods
  • Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
  • Simultaneous participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
  • Major surgery scheduled for the study period
  • Subject is a dependent person, eg: a family member or member of the Investigator's staff
  • Inability to cooperate with the study procedures for any reason, including language comprehension, psychiatric illness, inability to get to the study site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo
Active Comparator: Ortho Tri-Cyclen Lo
Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6
Time Frame: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
At Cycle 6 (28 days per Cycle)
Mean Length of Bleeding / Spotting Episodes in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
From Day 91 to Day 180
Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
From Day 1 to Day 90
Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
From Day 91 to Day 180
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
From Day 1 to Day 90
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
From Day 91 to Day 180
Mean Length of Spotting-only Episodes in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
From Day 91 to Day 180
Maximum Length of Spotting-only Episodes in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
From Day 91 to Day 180
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
From Day 1 to Day 90
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
From Day 91 to Day 180
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
Time Frame: At Cycle 1 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 1 (28 days per Cycle)
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
Time Frame: At Cycle 3 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 3 (28 days per Cycle)
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 6 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
Time Frame: At Cycle 1 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 1 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
Time Frame: At Cycle 3 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 3 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 6 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 1
Time Frame: At Cycle 1 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 1 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 3
Time Frame: At Cycle 3 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 3 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 6 (28 days per Cycle)
The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication
Time Frame: From Baseline to Cycle 6 (28 days per Cycle)
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.
From Baseline to Cycle 6 (28 days per Cycle)
The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication
Time Frame: From Baseline to Cycle 13 (28 days per Cycle)
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.
From Baseline to Cycle 13 (28 days per Cycle)
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Time Frame: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).
Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28
Time Frame: Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).
Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Time Frame: Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).
Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21
Time Frame: Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).
Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)
Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Time Frame: From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.
From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM
Time Frame: From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.
From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
Time Frame: Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)
Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28
Time Frame: Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)
Number of Days With Bleeding or Spotting in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
From Day 1 to Day 90
Number of Days With Bleeding or Spotting in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
From Day 91 to Day 180
Number of Days With Bleeding or Spotting in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
From Day 181 to Day 270
Number of Days With Bleeding or Spotting in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
From Day 271 to Day 360
Number of Bleeding / Spotting Episodes in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)
From Day 1 to Day 90
Number of Bleeding / Spotting Episodes in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)
From Day 91 to Day 180
Number of Bleeding / Spotting Episodes in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)
From Day 181 to Day 270
Number of Bleeding / Spotting Episodes in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)
From Day 271 to Day 360
Mean Length of Bleeding / Spotting Episodes in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.
From Day 1 to Day 90
Mean Length of Bleeding / Spotting Episodes in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
From Day 181 to Day 270
Mean Length of Bleeding / Spotting Episodes in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
From Day 271 to Day 360
Maximum Length of Bleeding / Spotting Episodes in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
From Day 181 to Day 270
Maximum Length of Bleeding / Spotting Episodes in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
From Day 271 to Day 360
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
From Day 181 to Day 270
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
From Day 271 to Day 360
Number of Days With Spotting-only in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
From Day 1 to Day 90
Number of Days With Spotting-only in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
From Day 91 to Day 180
Number of Days With Spotting-only in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
From Day 181 to Day 270
Number of Days With Spotting-only in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
From Day 271 to Day 360
Number of Spotting-only Episodes in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
From Day 1 to Day 90
Number of Spotting-only Episodes in Reference Period 2
Time Frame: From Day 91 to Day 180
Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
From Day 91 to Day 180
Number of Spotting-only Episodes in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
From Day 181 to Day 270
Number of Spotting-only Episodes in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
From Day 271 to Day 360
Mean Length of Spotting-only Episodes in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
From Day 1 to Day 90
Mean Length of Spotting-only Episodes in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
From Day 181 to Day 270
Mean Length of Spotting-only Episodes in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
From Day 271 to Day 360
Maximum Length of Spotting-only Episodes in Reference Period 1
Time Frame: From Day 1 to Day 90
Reference Period 1 is defined as Day 1 to Day 90 during study treatment.
From Day 1 to Day 90
Maximum Length of Spotting-only Episodes in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
From Day 181 to Day 270
Maximum Length of Spotting-only Episodes in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
From Day 271 to Day 360
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3
Time Frame: From Day 181 to Day 270
Reference Period 3 is defined as Day 181 to Day 270 during study treatment.
From Day 181 to Day 270
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4
Time Frame: From Day 271 to Day 360
Reference Period 4 is defined as Day 271 to Day 360 during study treatment.
From Day 271 to Day 360
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
Time Frame: At Cycle 1 (28 days per Cycle)
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
At Cycle 1 (28 days per Cycle)
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
Time Frame: At Cycle 3 (28 days per Cycle)
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
At Cycle 3 (28 days per Cycle)
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
At Cycle 6 (28 days per Cycle)
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
At Cycle 13 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 1
Time Frame: At Cycle 1 (28 days per Cycle)
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
At Cycle 1 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 3
Time Frame: At Cycle 3 (28 days per Cycle)
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
At Cycle 3 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
At Cycle 6 (28 days per Cycle)
Length of Withdrawal Bleeding Episodes at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.
At Cycle 13 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Time Frame: At Cycle 1 (28 days per Cycle)
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
At Cycle 1 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Time Frame: At Cycle 3 (28 days per Cycle)
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
At Cycle 3 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
At Cycle 6 (28 days per Cycle)
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
At Cycle 13 (28 days per Cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 1
Time Frame: At Cycle 1 (28 days per Cycle)
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
At Cycle 1 (28 days per Cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 3
Time Frame: At Cycle 3 (28 days per Cycle)
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
At Cycle 3 (28 days per Cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
At Cycle 6 (28 days per Cycle)
Onset of Withdrawal Bleeding Episodes at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).
At Cycle 13 (28 days per Cycle)
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 13 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 1
Time Frame: At Cycle 1 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
At Cycle 1 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 3
Time Frame: At Cycle 3 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
At Cycle 3 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
At Cycle 6 (28 days per Cycle)
Number of Intracyclic Bleeding Episodes at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)
At Cycle 13 (28 days per Cycle)
Maximum Length of Intracyclic Bleeding Episodes at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 13 (28 days per Cycle)
Number of Intracyclic Bleeding Days at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
At Cycle 13 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
Time Frame: At Cycle 1 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
At Cycle 1 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
Time Frame: At Cycle 3 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
At Cycle 3 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
At Cycle 6 (28 days per Cycle)
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.
At Cycle 13 (28 days per Cycle)
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6
Time Frame: Cycles 2 to 6 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Cycles 2 to 6 (28 days per Cycle)
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13
Time Frame: Cycles 2 to 13 (28 days per Cycle)
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Cycles 2 to 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
Time Frame: Baseline up to Cycle 6 (28 days per Cycle)
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 6 (28 days per Cycle)
Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment
Time Frame: Baseline up to Cycle 13 (28 days per Cycle)
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).
Baseline up to Cycle 13 (28 days per Cycle)
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
At Cycle 13 (28 days per Cycle)
Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6
Time Frame: At Cycle 6 (28 days per Cycle)
In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
At Cycle 6 (28 days per Cycle)
Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13
Time Frame: At Cycle 13 (28 days per Cycle)
In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.
At Cycle 13 (28 days per Cycle)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6
Time Frame: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6
Time Frame: Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)

Collaborators and Investigators

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Sponsor

Publications and helpful links

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 16, 2008

First Posted (Estimate)

September 17, 2008

Study Record Updates

Last Update Posted (Estimate)

July 19, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

July 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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