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NCT00477633 · ClinicalTrials.gov registry record · Phase 3
Study of Safety and Efficacy of an Oral Contraceptive
A Phase 3 study of Contraception, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,700
- Enrollment target
- 20
- Study locations
NCT00477633: Completed Phase 3 study of Contraception, sponsored by Warner Chilcott.
NCT00477633 is a Phase 3 study of Contraception that has completed, run by Warner Chilcott. The registered enrollment target is 1,700 participants, above the 431-participant average among 72 other Contraception trials with a reported enrollment target (294% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00477633, a Phase 3 study of Contraception, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,700 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
Primary Outcome
Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment
Conditions Studied
Interventions
- DRUG Norethindrone/ethinyl estradiol
Study Locations (20)
Florida
- Warner Chilcott Investigational Site - Boynton Beach
- Warner Chilcott Investigational Site - Brooksville
- Warner Chilcott Investigational Site - Clearwater
- Warner Chilcott Investigational Site - Gainesville
- Warner Chilcott Investigational Site - Jacksonville
- Warner Chilcott Investigational Site - Leesburg
- Warner Chilcott Investigational Site - Miami
- Warner Chilcott Investigational Site - Miami
Arizona
- Warner Chilcott Investigational Site - Chandler
- Warner Chilcott Investigational Site - Phoenix
- Warner Chilcott Investigational Site - Phoenix
- Warner Chilcott Investigational Site - Phoenix
- Warner Chilcott Investigational Site - Tempe
- Warner Chilcott Investigational Site - Tucson
California
- Warner Chilcott Investigational Site - San Diego
- Warner Chilcott Investigational Site - San Diego
- Warner Chilcott Investigational Site - Vista
Colorado
- Warner Chilcott Investigational Site - Castle Rock
- Warner Chilcott Investigational Site - Denver
- Warner Chilcott Investigational Site - Lakewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,700 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00477633 record still lists
NCT00477633 is an interventional study that assigns participants to a tested intervention. Its 1,700 participants enrollment target places it among the larger protocols in the corpus, above the 431-participant average among 72 other Contraception trials with a reported enrollment target (294% higher).
The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 1 intervention - of which Norethindrone/ethinyl estradiol is the first listed.
NCT00477633 names 20 study sites across 4 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT00477633 about?
NCT00477633 is a clinical study titled "Study of Safety and Efficacy of an Oral Contraceptive". This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
What is the current status of trial NCT00477633?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,700 participants. The study started on 2007-06. Estimated completion is 2009-02.
What conditions does trial NCT00477633 study?
This clinical trial studies the following conditions: Contraception.
What interventions are being tested in trial NCT00477633?
The interventions under investigation include: Norethindrone/ethinyl estradiol (DRUG).
Who is sponsoring clinical trial NCT00477633?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00477633 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00477633's enrollment target sits among peer trials
1,700 4th of 72 higher than 69 of 72 other Contraception trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraception 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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