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Sponsored by: |
Duramed Research |
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Information provided by: | Duramed Research |
ClinicalTrials.gov Identifier: | NCT00394771 |
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
Condition | Intervention | Phase |
---|---|---|
Breakthrough Bleeding |
Drug: DR-1031a Drug: DR-1031b Drug: DR-1031c Drug: Seasonale |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 400 |
Study Start Date: | October 2006 |
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-1031a
1 tablet daily
|
2: Experimental |
Drug: DR-1031b
1 tablet daily
|
3: Experimental |
Drug: DR-1031c
1 tablet daily
|
4: Active Comparator |
Drug: Seasonale
1 tablet daily
|
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Duramed Medical Monitor | Duramed Research |
Responsible Party: | Duramed Research, Inc ( Duramed Research ) |
Study ID Numbers: | DR-ASC-201 |
Study First Received: | October 30, 2006 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00394771 |
Health Authority: | United States: Food and Drug Administration |
oral contraceptives breakthrough bleeding spotting |
Genital Diseases, Female Uterine Hemorrhage Metrorrhagia Uterine Diseases Hemorrhage |
Pathologic Processes |