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NCT03573336 · ClinicalTrials.gov registry record · Phase 2
Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis
A Phase 2 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT03573336: Clinical Trial Phase 2 study, sponsored by Bayer.
NCT03573336 is a Phase 2 study that was terminated before completion, run by Bayer. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03573336, a Phase 2 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis. The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis. With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.
Primary Outcome
Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean 'worst pelvic pain' was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) during a study period divided by number of days with pain assessment in that study period. This
Interventions
- DRUG Matching Placebo
- DRUG Vilaprisan (BAY1002670)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-07-04 |
| Est. Completion | 2020-11-26 |
| Phase | Phase 2 |
Why NCT03573336 stopped before completion
NCT03573336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT03573336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03573336 about?
NCT03573336 is a clinical study titled "Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis". The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis. The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symp...
What is the current status of trial NCT03573336?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2018-07-04. Estimated completion is 2020-11-26.
What interventions are being tested in trial NCT03573336?
The interventions under investigation include: Matching Placebo (DRUG), Vilaprisan (BAY1002670) (DRUG).
Who is sponsoring clinical trial NCT03573336?
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 NCT03573336's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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