A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021
Information source: Duramed Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: DR-1021 (Drug); Desogestrel 150mcg /Ethinyl Estradiol (EE) 20mcg-10mcg EE (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Duramed Research Official(s) and/or principal investigator(s):
Duramed Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc.
Summary
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.
Clinical Details
Official title: A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Compare differences in hormone patterns (follicle stimulating hormone [FSH], inhibin-B, and estradiol)and ovarian follicular development
Secondary outcome: Analyze bleeding patterns
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Duramed Investigational Site, Lawrenceville, New Jersey 08648, United States
Duramed Investigational Site, Columbus, Ohio 43213, United States
Duramed Investigational Site, Philadelphia, Pennsylvania 19114, United States
Duramed Investigational Site, Seattle, Washington 98105, United States
Additional Information
Starting date: October 2007
Ending date: May 2008
Last updated: February 25, 2008
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