Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00996580 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
A Phase 3 study of Pregnancy Prevention, sponsored by Teva Women's Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,597
- Enrollment target
- 20
- Study locations
NCT00996580: Completed Phase 3 study of Pregnancy Prevention, sponsored by Teva Women's Health.
NCT00996580 is a Phase 3 study of Pregnancy Prevention that has completed, run by Teva Women's Health. The registered enrollment target is 3,597 participants, above the 95-participant average among 4 other Pregnancy Prevention trials with a reported enrollment target (3686% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996580, a Phase 3 study of Pregnancy Prevention, has completed, sponsored by Teva Women's Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,597 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. 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
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). 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-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive fail
Conditions Studied
Interventions
- DRUG DR-103
Study Locations (20)
California
- Teva Women's Health Research Investigational Site - Anaheim
- Teva Women's Health Research Investigational Site - Irvine
- Teva Women's Health Research Investigational Site - Los Angeles
- Teva Women's Health Research Investigational Site - National City
- Teva Women's Health Research Investigational Site - San Diego
- Teva Women's Health Research Investigational Site - San Diego
- Teva Women's Health Research Investigational Site - San Diego
- Teva Women's Health Research Investigational Site - San Francisco
- Teva Women's Health Research Investigational Site - Torrance
Arizona
- Teva Women's Health Research Investigational Site - Phoenix
- Teva Women's Health Research Investigational Site - Phoenix
- Teva Women's Health Research Investigational Site - Tucson
Florida
- Teva Women's Health Research Investigational Site - Clearwater
- Teva Women's Health Research Investigational Site - Jacksonville
- Teva Women's Health Research Investigational Site - Leesburg
Colorado
- Teva Women's Health Research Investigational Site - Colorado Springs
- Teva Women's Health Research Investigational Site - Pueblo
Alabama
- Teva Women's Health Research Investigational Site - Montgomery
Arkansas
- Teva Women's Health Research Investigational Site - Little Rock
District of Columbia
- Teva Women's Health Research Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,597 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
What the finished NCT00996580 record still lists
NCT00996580 is an interventional study that assigns participants to a tested intervention. Its 3,597 participants enrollment target places it among the larger protocols in the corpus, above the 95-participant average among 4 other Pregnancy Prevention trials with a reported enrollment target (3686% higher).
The record links to 1 condition, with Pregnancy Prevention appearing as the primary indexed condition, and to 1 intervention - of which DR-103 is the first listed.
NCT00996580 names 20 study sites across 7 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT00996580 about?
NCT00996580 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of DR-103 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-103. 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 NCT00996580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,597 participants. The study started on 2009-10. Estimated completion is 2011-09.
What conditions does trial NCT00996580 study?
This clinical trial studies the following conditions: Pregnancy Prevention.
What interventions are being tested in trial NCT00996580?
The interventions under investigation include: DR-103 (DRUG).
Who is sponsoring clinical trial NCT00996580?
This trial is sponsored by Teva Women's Health, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00996580 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
Similar trials for Pregnancy Prevention
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Phase II Study of Ovulation in Obese Women
RECRUITING · Phase 2
-
Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days
RECRUITING · Phase 2
-
Healthy Adolescent Transitions (HAT)
COMPLETED · Phase 2
-
The Impact of Online Educator Mircoskill Training and Parent Microskill Training on Student Sexual-Health Related Outcomes
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06088498 · 3,600 participants · Phase 2
App for Reducing Cravings to Smoke
- NCT06501118 · 3,600 participants · NA
Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
- NCT06919419 · 3,600 participants · NA
HOTSPOT Study: Implement and Evaluate the PrEP (Pre-exposure Prophylaxis) Implementation Strategy
- NCT07091032 · 3,600 participants · NA
Building Connections
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia