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Sponsored by: |
Duramed Research |
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Information provided by: | Duramed Research |
ClinicalTrials.gov Identifier: | NCT00544882 |
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.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: DR-1021 Drug: Desogestrel 150mcg /Ethinyl Estradiol (EE) 20mcg-10mcg EE |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021 |
Estimated Enrollment: | 60 |
Study Start Date: | October 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: DR-1021
1 tablet daily
|
2: Active Comparator |
Drug: Desogestrel 150mcg /Ethinyl Estradiol (EE) 20mcg-10mcg EE
1 tablet daily
|
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Duramed Investigational Site | |
Lawrenceville, New Jersey, United States, 08648 | |
United States, Ohio | |
Duramed Investigational Site | |
Columbus, Ohio, United States, 43213 | |
United States, Pennsylvania | |
Duramed Investigational Site | |
Philadelphia, Pennsylvania, United States, 19114 | |
United States, Washington | |
Duramed Investigational Site | |
Seattle, Washington, United States, 98105 |
Study Chair: | Duramed Protocol Chair | Duramed Research, Inc. |
Responsible Party: | Duramed Research, Inc. ( Duramed Protocol Chair ) |
Study ID Numbers: | DR-DSG-302 |
Study First Received: | October 12, 2007 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00544882 |
Health Authority: | United States: Food and Drug Administration |
Desogestrel Estradiol 3-benzoate Estradiol valerate Ethinyl Estradiol |
Estradiol 17 beta-cypionate Healthy Polyestradiol phosphate Estradiol |
Estrogens Contraceptive Agents Therapeutic Uses Progestins Contraceptives, Oral Physiological Effects of Drugs |
Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic Reproductive Control Agents Hormones Pharmacologic Actions |