Trials / Terminated
TerminatedNCT03400943
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
A Randomized, Parallel-group, Double-blind and Open-label 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
- 93 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vilaprisan (BAY1002670) | 2 mg of Vilaprisan once daily up to 2 x 12 weeks |
| DRUG | Placebo | Matching placebo was administered to group B1 and B2. |
Timeline
- Start date
- 2018-01-17
- Primary completion
- 2019-06-09
- Completion
- 2022-04-06
- First posted
- 2018-01-17
- Last updated
- 2023-05-03
- Results posted
- 2021-06-11
Locations
103 sites across 9 countries: United States, Bulgaria, China, Czechia, Israel, Malaysia, New Zealand, Singapore, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03400943. Inclusion in this directory is not an endorsement.