Official Title: “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 Type: Interventional

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

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: levonorestrel/EE 0.15/0.03 and EE 0.01 mg tablets
  • 1 tablet daily by mouth
• Drug: Placebo tablet
  • 1 tablet daily by mouth

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Change in patient reported severity of menstrual pain
  • Time Frame: 13-week treatment period
    Safety Issue?: No

Secondary Measures

• Change in total menstrual pain from weeks 1-13
  • Time Frame: 13-week treatment period
    Safety Issue?: No
• Incidence of menstrual bleeding and /or spotting
  • Time Frame: 13-week treatment period
    Safety Issue?: No
• Number of days missed from school/work or other activities
  • Time Frame: 13-week treatment period
    Safety Issue?: No
• Analgesic use
  • Time Frame: 13-week treatment period
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Overall Contact: C. M. O'Leary, PharmD 610-747-2679 coleary@barrlabs.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00196313

Study ID Number: DR-PSE-306

ClinicalTrials.gov Identifier: NCT00196313

Health Authority: United States: Food and Drug Administration