Trials / Terminated
TerminatedNCT03342859
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned
An Open-label, Parallel Group, Multi-center Study to Investigate Pharmacodynamic Effects After Daily Administration of Vilaprisan or Ulipristal Acetate for 8-12 Weeks in Patients With Uterine Fibroids for Whom Surgery (Hysterectomy or Myomectomy) is Planned
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the clinical effects of vilaprisan and ulipristal acetate at molecular and cellular level on uterine and fibroid tissue taken from patients (after surgery / biopsy)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vilaprisan, BAY1002670 | Daily single oral doses of 2 mg vilaprisan over 8-12 weeks |
| DRUG | Ulipristal | Daily single oral doses of 5 mg ulipristal over 8-12 weeks |
Timeline
- Start date
- 2017-11-16
- Primary completion
- 2018-12-17
- Completion
- 2020-01-13
- First posted
- 2017-11-17
- Last updated
- 2021-01-06
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03342859. Inclusion in this directory is not an endorsement.