Official Title: “A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen”

This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary

Study Type: Interventional

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

Study Primary Completion Date: February 2008

This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.

Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,

The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.

Intervention(s) in this Clinical Trial

• Drug: DR-1031a
  • 1 tablet daily
• Drug: DR-1031b
  • 1 tablet daily
• Drug: DR-1031c
  • 1 tablet daily
• Drug: Seasonale
  • 1 tablet daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Active Comparator: 4

Primary Measures

• Total number of bleeding and/or spotting days during active treatment period.
  • Time Frame: Each cycle
    Safety Issue?: Yes

Secondary Measures

• Total number of bleeding days during active treatment period
  • Time Frame: Each cycle
    Safety Issue?: Yes
• Timing and severity of bleeding
  • Time Frame: Each cycle
    Safety Issue?: Yes
• Onset,duration,severity of scheduled withdrawal bleeding
  • Time Frame: Each cycle
    Safety Issue?: Yes
• Number of subjects reporting hormone-related symptoms
  • Time Frame: Each cycle
    Safety Issue?: Yes
• Adverse events reported by subjects and investigators
  • Time Frame: Active treatment period
    Safety Issue?: Yes

Inclusion Criteria:

• Premenopausal
• Not pregnant or breastfeeding
• Agree to use back-up non-hormonal contraception for study period

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duramed Medical Monitor Principal Investigator Duramed Research  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00394771

Study ID Number: DR-ASC-201

ClinicalTrials.gov Identifier: NCT00394771

Health Authority: United States: Food and Drug Administration