Trials / Withdrawn
WithdrawnNCT03699176
Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is 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 are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vilaprisan (BAY1002670) | 2 mg, once daily, oral |
| DRUG | Placebo | Once daily, oral |
Timeline
- Start date
- 2018-10-27
- Primary completion
- 2019-12-25
- Completion
- 2019-12-25
- First posted
- 2018-10-09
- Last updated
- 2020-01-18
Locations
8 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03699176. Inclusion in this directory is not an endorsement.