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NCT00196326 · ClinicalTrials.gov registry record · Phase 3
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
A Phase 3 study, sponsored by Duramed Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,235
- Enrollment target
NCT00196326: Completed Phase 3 study, sponsored by Duramed Research.
NCT00196326 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 2,235 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (190% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00196326, a Phase 3 study, has completed, sponsored by Duramed Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,235 participants
- Enrollment target
Study Summary
This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. 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
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregn
Interventions
- DRUG DR-1011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,235 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-06 |
| Phase | Phase 3 |
What the finished NCT00196326 record still lists
NCT00196326 is an interventional study that assigns participants to a tested intervention. Its 2,235 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (190% higher).
The record links to 0 conditions, and to 1 intervention - of which DR-1011 is the first listed.
NCT00196326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00196326 about?
NCT00196326 is a clinical study titled "Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive". This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
What is the current status of trial NCT00196326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,235 participants. The study started on 2005-06. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00196326?
The interventions under investigation include: DR-1011 (DRUG).
Who is sponsoring clinical trial NCT00196326?
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 NCT00196326's enrollment target sits among peer trials
2,235 95th of 2000 higher than 1,906 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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