A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

A Multicenter Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval to Placebo for the Treatment of Cyclic Pelvic Pain in Adolescents

This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets; Drug: Placebo tablet

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218-1088
      • Duramed Investigational Site
  • Georgia
    • Decatur, Georgia, United States, 30034
      • Duramed Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Duramed Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Duramed Investigational Site
  • Ohio
    • Cincinatti, Ohio, United States, 45229
      • Duramed Investigational Site
    • Cleveland, Ohio, United States, 44109
      • Duramed Investigational Site
    • Columbus, Ohio, United States, 43205
      • 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, 15213
      • Duramed Investigational Site
    • Willow Grove, Pennsylvania, United States, 19090
      • Duramed Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Duramed Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Duramed Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Sexually naïve and agree to abstain from sex during the study
• Moderate to severe menstrual-related pelvic pain
• Regular spontaneous menstrual cycles

Exclusion Criteria:

• Any contraindication to the use of oral contraceptives
• Treatment with an oral contraceptive within the previous 3 months
• Previous treatment failure with an extended oral contraceptive regimen

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Drug: Placebo tablet; 1 tablet daily by mouth
Experimental: 1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet	Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets; 1 tablet daily by mouth; Other Names: Seasonique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Average Severity for Abdominal/Pelvic Pain	Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")	Baseline to end of 13-week treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain	Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13. The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")	Baseline to end of Week 13
Incidence of Menstrual Bleeding and /or Spotting		Baseline to end of Week 13
Number of Days Missed From School/Work or Other Activities		13-week treatment period
Analgesic Use	number of days analgesic (pain) medication was used over the 13 week treatment period	13-week treatment period

Collaborators and Investigators

• Sponsor: Duramed Research

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: oral contraceptives; dysmenorrhea; cyclic pelvic pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Dysmenorrhea; Pelvic Pain; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: DR-PSE-306