Trials / Terminated
TerminatedNCT03573336
Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis
A Randomized, Double-blind, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Two Different Doses of Vilaprisan (BAY1002670) Versus Placebo in Women With Symptomatic Endometriosis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vilaprisan (BAY1002670) | Intake orally, once daily |
| DRUG | Matching Placebo | Intake orally, once daily |
Timeline
- Start date
- 2018-07-04
- Primary completion
- 2019-03-18
- Completion
- 2020-11-26
- First posted
- 2018-06-29
- Last updated
- 2022-05-04
- Results posted
- 2021-01-22
Locations
23 sites across 8 countries: United States, Austria, Canada, Czechia, Finland, Italy, Japan, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03573336. Inclusion in this directory is not an endorsement.