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NCT03400943 · ClinicalTrials.gov registry record · Phase 3
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
A Phase 3 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 93
- Enrollment target
NCT03400943: Clinical Trial Phase 3 study, sponsored by Bayer.
NCT03400943 is a Phase 3 study that was terminated before completion, run by Bayer. The registered enrollment target is 93 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03400943, a Phase 3 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 93 participants
- Enrollment target
Study Summary
The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo. The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
Primary Outcome
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
Interventions
- DRUG Placebo
- DRUG Vilaprisan (BAY1002670)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2022-04-06 |
| Phase | Phase 3 |
Why NCT03400943 stopped before completion
NCT03400943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03400943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03400943 about?
NCT03400943 is a clinical study titled "Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)". The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo. The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
What is the current status of trial NCT03400943?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2018-01-17. Estimated completion is 2022-04-06.
What interventions are being tested in trial NCT03400943?
The interventions under investigation include: Placebo (DRUG), Vilaprisan (BAY1002670) (DRUG).
Who is sponsoring clinical trial NCT03400943?
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 NCT03400943's enrollment target sits among peer trials
93 1722nd of 2000 higher than 278 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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