Trials / Terminated
TerminatedNCT03400956
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vilaprisan (BAY1002670) | Orally, coated tablet 2 mg, once daily |
| DRUG | Placebo | Orally, coated tablet, once daily |
Timeline
- Start date
- 2018-01-24
- Primary completion
- 2019-03-23
- Completion
- 2021-06-30
- First posted
- 2018-01-17
- Last updated
- 2022-06-30
- Results posted
- 2021-04-30
Locations
87 sites across 5 countries: United States, Czechia, Japan, Russia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03400956. Inclusion in this directory is not an endorsement.