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NCT01178125 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,858
- Enrollment target
NCT01178125: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01178125 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 2,858 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (270% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01178125, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,858 participants
- Enrollment target
Study Summary
This is an open-label, single treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.
Primary Outcome
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contrace
Interventions
- DRUG DR-102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,858 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-01 |
| Phase | Phase 3 |
What the finished NCT01178125 record still lists
NCT01178125 is an interventional study that assigns participants to a tested intervention. Its 2,858 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 (270% higher).
The record links to 0 conditions, and to 1 intervention - of which DR-102 is the first listed.
NCT01178125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01178125 about?
NCT01178125 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy". This is an open-label, single treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.
What is the current status of trial NCT01178125?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,858 participants. The study started on 2010-08. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01178125?
The interventions under investigation include: DR-102 (DRUG).
Who is sponsoring clinical trial NCT01178125?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01178125's enrollment target sits among peer trials
2,858 81st of 2000 higher than 1,920 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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