Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: DR-1011

• Study Type: Interventional
• Enrollment (Actual): 2235
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Duramed Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Duramed Investigational Site
    • Phoenix, Arizona, United States, 85031
      • Duramed Investigational Site
    • Phoenix, Arizona, United States, 85032
      • Duramed Investigational Site
    • Tucson, Arizona, United States, 85712
      • Duramed Investigational Site
  • California
    • San Diego, California, United States, 92108
      • Duramed Investigational Site
    • San Diego, California, United States, 92103
      • Duramed Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Duramed Investigational Site
    • Colorado Springs, Colorado, United States, 80907
      • Duramed Investigational Site
    • Denver, Colorado, United States, 80202
      • Duramed Investigational Site
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Duramed Investigational Site
  • Florida
    • Coral Cables, Florida, United States, 33134
      • Duramed Investigational Site
    • Hollywood, Florida, United States, 33024
      • Duramed Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Duramed Investigational Site
    • Leesburg, Florida, United States, 34748
      • Duramed Investigational Site
    • Miami, Florida, United States, 33143
      • Duramed Investigational Site
    • Palm Springs, Florida, United States, 33437
      • Duramed Investigational Site
    • Sarasota, Florida, United States, 34239
      • Duramed Investigational Site
    • Tampa, Florida, United States, 33607
      • Duramed Investigational Site
  • Georgia
    • Decatur, Georgia, United States, 30034
      • Duramed Investigational Site
    • Douglasville, Georgia, United States, 30134
      • Duramed Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83704
      • Duramed Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Duramed Investigational Site
  • Kansas
    • Shawnee Mission, Kansas, United States, 66216
      • Duramed Investigational Site
    • Topeka, Kansas, United States, 66614
      • Duramed Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • Duramed Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64106
      • Duramed Investigational Site
    • St. Louis, Missouri, United States, 63110
      • Duramed Investigational Site
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Duramed Investigational Site
    • Moorestown, New Jersey, United States, 08057
      • Duramed Investigational Site
    • New Brunswick, New Jersey, United States, 08901
      • Duramed Investigational Site
  • New York
    • Rochester, New York, United States, 14609
      • Duramed Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28222
      • Duramed Investigational Site
    • Wilmington, North Carolina, United States, 28412
      • Duramed Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Duramed Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Duramed Investigational Site
    • Columbus, Ohio, United States, 43205
      • Duramed Investigational Site
  • Oklahoma
    • Oklahoma, Oklahoma, United States, 73112
      • Duramed Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Duramed Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Duramed Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15206
      • Duramed Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Duramed Investigational Site
    • Willow Grove, Pennsylvania, United States, 19090
      • Duramed Investigational Site
  • Texas
    • Dallas, Texas, United States, 75390
      • Duramed Investigational Site
    • Houston, Texas, United States, 77030
      • Duramed Investigational Site
    • San Antonio, Texas, United States, 78229
      • Duramed Investigational Site
    • Waco, Texas, United States, 76712
      • Duramed Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Duramed Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23602
      • Duramed Investigational Site
    • Norfolk, Virginia, United States, 23507
      • Duramed Investigational Site
    • Richmond, Virginia, United States, 23226
      • Duramed Investigational Site
  • Washington
    • Lakewood, Washington, United States, 98499
      • Duramed Investigational Site
    • Seattle, Washington, United States, 98105
      • Duramed Investigational Site
    • Spokane, Washington, United States, 99207
      • Duramed Investigational Site
    • Tacoma, Washington, United States, 98405
      • Duramed Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Premenopausal
• Not pregnant or breastfeeding
• Sexually active at risk of pregnancy

Exclusion Criteria:

• Any contraindication to the use of oral contraceptives
• Pregnancy within the last 3 months
• Smoking > 10 cigarettes per day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DR-1011; Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.

Drug: DR-1011; Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).; Other Names: levonorgestrel/ethinyl estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy	Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication. Three denominators are reported; excluding cycles where other birth control methods (BCMs) was used; all complete cycles; compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)	up to one year
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy	Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication. Three denominators are reported; excluding cycles where other birth control methods (BCMs) was used; all complete cycles; compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)	up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Treatment-Emergent Adverse Events	Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.	Day 1 up to one year

Collaborators and Investigators

• Sponsor: Duramed Research

Publications and helpful links

General Publications

• Kroll R, Reape KZ, Margolis M. The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol. Contraception. 2010 Jan;81(1):41-8. doi: 10.1016/j.contraception.2009.07.003.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): November 16, 2016
• Last Update Submitted That Met QC Criteria: September 28, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: oral contraceptives; pregnancy prevention
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Levonorgestrel; Estradiol; Ethinyl Estradiol
• Other Study ID Numbers: DR-PSE-309