A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

Verified by: Duramed Research, June 2011
First Received: October 12, 2007 | Last Updated: June 8, 2011 | Phase: Phase 3 | Start Date: October 2007
Overall Status: Completed | Estimated Enrollment: 60
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This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021. Study duration will be approximately 12-20 weeks including a screening period, a 28-day baseline cycle, a 28-day randomized cycle, and a 21-day follow-up cycle. Participants will receive one of two treatments (either Mircette oral contraceptive or DR-1021). Participants will have blood draws and...

Brief Summary

Official Title: “A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021”

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021. Study duration will be approximately 12-20 weeks including a screening period, a 28-day baseline cycle, a 28-day randomized cycle, and a 21-day follow-up cycle. Participants will receive one of two treatments (either Mircette oral contraceptive or DR-1021).

Participants will have blood draws and transvaginal ultrasounds at clinic visits and be asked to complete a data diary.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

  • Drug: DR-1021
    • 1 tablet daily
  • Drug: Desogestrel 150mcg /Ethinyl Estradiol (EE) 20mcg-10mcg EE
    • 1 tablet daily

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Compare differences in hormone patterns (follicle stimulating hormone [FSH], inhibin-B, and estradiol)and ovarian follicular development
    • Time Frame: Throughout the study
      Safety Issue?: No

Secondary Measures

  • Analyze bleeding patterns
    • Time Frame: Throughout the study
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Premenopausal
  • Weight <200 lbs
  • Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1
  • Others as dictated by protocol

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
  • Breast feeding
  • Smoking > 10 cigarettes per day
  • Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin
  • [Accutane])
  • Others as dictated by protocol

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

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

Clinical Trial Investigator Information

Lead Investigator: Duramed Research Industry

Overall Clinical Trial Officials and Contacts

Duramed Protocol Chair Study Chair Duramed Research, Inc.  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00544882

Study ID Number: DR-DSG-302

ClinicalTrials.gov Identifier: NCT00544882

Health Authority: United States: Food and Drug Administration

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