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NCT00394771 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
A Phase 2 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 567
- Enrollment target
NCT00394771: Completed Phase 2 study, sponsored by Duramed Research.
NCT00394771 is a Phase 2 study that has completed, run by Duramed Research. The registered enrollment target is 567 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (326% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00394771, a Phase 2 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 567 participants
- Enrollment target
Study Summary
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
Primary Outcome
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Interventions
- DRUG DR-1031
- DRUG Seasonale®
- DRUG Portia®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 567 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00394771 record still lists
NCT00394771 is an interventional study that assigns participants to a tested intervention. The registered 567 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (326% higher).
The record links to 0 conditions, and to 3 interventions - of which DR-1031 is the first listed.
NCT00394771 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00394771 about?
NCT00394771 is a clinical study titled "A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale". 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...
What is the current status of trial NCT00394771?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 567 participants. The study started on 2006-10. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00394771?
The interventions under investigation include: DR-1031 (DRUG), Seasonale® (DRUG), Portia® (DRUG).
Who is sponsoring clinical trial NCT00394771?
This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00394771's enrollment target sits among peer trials
567 60th of 2000 higher than 1,941 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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