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NCT03194646 · ClinicalTrials.gov registry record · Phase 3
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
A Phase 3 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,272
- Enrollment target
NCT03194646: Clinical Trial Phase 3 study, sponsored by Bayer.
NCT03194646 is a Phase 3 study that was terminated before completion, run by Bayer. The registered enrollment target is 1,272 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03194646, a Phase 3 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,272 participants
- Enrollment target
Study Summary
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
Primary Outcome
The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.
Interventions
- OTHER Standard of care
- DRUG Vilaprisan (BAY1002670)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,272 participants |
| Start Date | 2017-06-30 |
| Est. Completion | 2024-07-11 |
| Phase | Phase 3 |
Why NCT03194646 stopped before completion
NCT03194646 is an interventional study that assigns participants to a tested intervention. Its 1,272 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 (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT03194646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03194646 about?
NCT03194646 is a clinical study titled "Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids". The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
What is the current status of trial NCT03194646?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,272 participants. The study started on 2017-06-30. Estimated completion is 2024-07-11.
What interventions are being tested in trial NCT03194646?
The interventions under investigation include: Standard of care (OTHER), Vilaprisan (BAY1002670) (DRUG).
Who is sponsoring clinical trial NCT03194646?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03194646's enrollment target sits among peer trials
1,272 202nd of 2000 higher than 1,799 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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