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NCT03633799 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS
A Phase 3 study of Women at Risk for Pregnancy, sponsored by Sebela Women's Health.
- Active
- Registry status
- Phase 3
- Development phase
- 1,620
- Enrollment target
- 20
- Study locations
NCT03633799: Active Phase 3 study of Women at Risk for Pregnancy, sponsored by Sebela Women's Health.
NCT03633799 is a Phase 3 study of Women at Risk for Pregnancy that is active but no longer recruiting, run by Sebela Women's Health. The registered enrollment target is 1,620 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (110% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03633799, a Phase 3 study of Women at Risk for Pregnancy, is active but no longer recruiting, sponsored by Sebela Women's Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,620 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept
Primary Outcome
Contraceptive efficacy through 3 years of use, as assessed by the Pearl Index. The Pearl Index is calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. On-treatment pregnancy is defined as the estimated conception date being on or after the insertion date (must be a successful insertion) and no more than 7 days after the study drug is removed or expelled. One women year is defined as comprising thirteen 28-day cycles. A lower Pearl Index indicates greater contrace
Conditions Studied
Interventions
- DRUG VeraCept
Study Locations (20)
California
- Essential Access Health - Berkeley
- Essential Access Health - Los Angeles
- Empire Clinical Research - Pomona
- University of California, Davis Health System - Sacramento
- M3 Wake Research (formerly Women's Health Care Research) - San Diego
- M3 Wake Research (formerly Medical Center for Clinical Research) - San Diego
- Stanford University, Medical Center, Obstetrics and Gynecolocy - Stanford
Arizona
- MomDoc Women's Health Research - Scottsdale
- Copperstate OB/GYN Associates - Tucson
Georgia
- Emory University School of Medicine - Atlanta
- Soapstone Center for Clinical Research - Decatur
Indiana
- Women's Health Advantage - Fort Wayne
- Indiana University - Indianapolis
Colorado
- Velocity Clinical Research (formerly Downtown Women's Health Care) - Englewood
Florida
- Altus Research, Inc - Lake Worth
Idaho
- Clinical Research Prime - Idaho Falls
Louisiana
- Praetorian Pharmaceutical Research - Marrero
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,620 participants |
| Start Date | 2018-08-22 |
| Est. Completion | 2027-09-22 |
| Phase | Phase 3 |
What the registry record for NCT03633799 still lists
NCT03633799 is an interventional study that assigns participants to a tested intervention. Its 1,620 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 (110% higher).
The record links to 1 condition, with Women at Risk for Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which VeraCept is the first listed.
NCT03633799 names 20 study sites across 11 states, led by California, Arizona, Georgia.
Frequently Asked Questions
What is clinical trial NCT03633799 about?
NCT03633799 is a clinical study titled "Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS". To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept
What is the current status of trial NCT03633799?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,620 participants. The study started on 2018-08-22. Estimated completion is 2027-09-22.
What conditions does trial NCT03633799 study?
This clinical trial studies the following conditions: Women at Risk for Pregnancy.
What interventions are being tested in trial NCT03633799?
The interventions under investigation include: VeraCept (DRUG).
Who is sponsoring clinical trial NCT03633799?
This trial is sponsored by Sebela Women's Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03633799 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03633799's enrollment target sits among peer trials
1,620 141st of 2000 higher than 1,860 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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