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NCT00455156 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring
A Phase 3 study, sponsored by Premier Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
NCT00455156: Completed Phase 3 study, sponsored by Premier Research.
NCT00455156 is a Phase 3 study that has completed, run by Premier Research. The registered enrollment target is 1,200 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00455156, a Phase 3 study, has completed, sponsored by Premier Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception.
Primary Outcome
The Pearl Index derived from using all cycles for which back up contraception is not used will be the primary efficacy endpoint. The Pearl Index is used to indicate how many women out of 100 would get pregnant using a specific birth control method over a year. It uses the formula: (Pregnancies x 12 x 100) / (Women x Months of study). The lower the Pearl Index, the more effective the contraceptive.
Interventions
- DRUG 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2006-12 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
What the finished NCT00455156 record still lists
NCT00455156 is an interventional study that assigns participants to a tested intervention. Its 1,200 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 (55% higher).
The record links to 0 conditions, and to 1 intervention - of which 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR) is the first listed.
NCT00455156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00455156 about?
NCT00455156 is a clinical study titled "Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring". The purpose of this study is to evaluate the one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception.
What is the current status of trial NCT00455156?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2006-12. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00455156?
The interventions under investigation include: 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR) (DRUG).
Who is sponsoring clinical trial NCT00455156?
This trial is sponsored by Premier Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00455156's enrollment target sits among peer trials
1,200 220th of 2000 higher than 1,773 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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