Official Title: “A Study to Compare the Efficacy of an Extended-Cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-Free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain”

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 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

• Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
  • 1 tablet daily
• Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo
  • 1 tablet daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Change from baseline in the clinical assessment of dysmenorrhea
  • Time Frame: Baseline to Week 4,8,12,24, and 26 or early discontinuation
    Safety Issue?: No

Secondary Measures

• Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)
  • Time Frame: Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation
    Safety Issue?: No
• Incidence of menstrual bleeding and/or spotting
  • Time Frame: Duration of study
    Safety Issue?: No
• Analgesic use
  • Time Frame: Duration of study
    Safety Issue?: No

Inclusion Criteria:

• Moderate to severe menstrual-related pain
• Regular spontaneous menstrual cycles

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duramed Protocol Chair Study Chair Duramed Research, Inc.  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00196365

Study ID Number: DR-PSE-305

ClinicalTrials.gov Identifier: NCT00196365

Health Authority: United States: Food and Drug Administration