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NCT01140217 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception
A Phase 3 study of Contraceptive Usage, sponsored by Watson Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,659
- Enrollment target
- 20
- Study locations
NCT01140217: Completed Phase 3 study of Contraceptive Usage, sponsored by Watson Pharmaceuticals.
NCT01140217 is a Phase 3 study of Contraceptive Usage that has completed, run by Watson Pharmaceuticals. The registered enrollment target is 1,659 participants, above the 477-participant average among 11 other Contraceptive Usage trials with a reported enrollment target (248% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01140217, a Phase 3 study of Contraceptive Usage, has completed, sponsored by Watson Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,659 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.
Primary Outcome
The pregnancy rate will be calculated using the Pearl Index that defined as 1300\*Number of pregnancies/Number of cycles of treatment.
Conditions Studied
Interventions
- DRUG Norethindrone Acetate
Study Locations (20)
Florida
- Watson Investigational Site - Aventura
- Watson Investigational Site - Daytona Beach
- Watson Investigational Site - Jacksonville
- Watson Investigational Site - Lake Worth
- Watson Investigational Site - Miami
- Watson Investigational Site - North Miami
- Watson Investigational Site - Pinellas Park
- Watson Investigational Site - Sarasota
Alabama
- Watson Investigational Site - Birmingham
- Watson Investigational Site - Mobile
- Watson Investigational Site - Montgomery
California
- Watson Investigational Site - Garden Grove
- Watson Investigational Site - La Mesa
- Watson Investigational Site - San Diego
Arizona
- Watson Investigational Site - Chandler
Arkansas
- Watson Investigational Site - Little Rock
Colorado
- Watson Investigational Site - Denver
Delaware
- Watson Investigational Site - Newark
District of Columbia
- Watson Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,659 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT01140217 record still lists
NCT01140217 is an interventional study that assigns participants to a tested intervention. Its 1,659 participants enrollment target places it among the larger protocols in the corpus, above the 477-participant average among 11 other Contraceptive Usage trials with a reported enrollment target (248% higher).
The record links to 1 condition, with Contraceptive Usage appearing as the primary indexed condition, and to 1 intervention - of which Norethindrone Acetate is the first listed.
NCT01140217 names 20 study sites across 9 states, led by Florida, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT01140217 about?
NCT01140217 is a clinical study titled "Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception". The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.
What is the current status of trial NCT01140217?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,659 participants. The study started on 2010-05. Estimated completion is 2012-03.
What conditions does trial NCT01140217 study?
This clinical trial studies the following conditions: Contraceptive Usage.
What interventions are being tested in trial NCT01140217?
The interventions under investigation include: Norethindrone Acetate (DRUG).
Who is sponsoring clinical trial NCT01140217?
This trial is sponsored by Watson Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01140217 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01140217's enrollment target sits among peer trials
1,659 2nd of 11 the highest of 11 other Contraceptive Usage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraceptive Usage 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.
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