Mode of action study of vilaprisan
Research type
Research Study
Full title
A randomized, 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 hysterectomy is planned
IRAS ID
225724
Contact name
Hilary Critchley
Contact email
Eudract number
2017-000468-13
Duration of Study in the UK
1 years, 9 months, 7 days
Research summary
There are several surgical approaches for treatment of womb fibroids but as the only definitive treatment, a hysterectomy (removal of womb) removes potential for fertility. As a medical treatment progesterone receptor modulators (PRMs) are a new class of drugs which quickly reduce the amount of bleeding as well as the size of the fibroids. Vilaprisan is not yet approved for sale but it has been studied in several clinical studies with patients. Vilaprisan will be compared to ulipristal acetate, that is already approved for symptomatic treatment of womb fibroids. The clinical effects of those PRMs have been proven in trials, but the molecular details how these drugs act are not fully understood. Therefore, the purpose of this clinical study is to investigate their mode of action at molecular and cellular level on uterine and fibroid tissue taken from patients.
Premenopausal women participating in this study will have planned a hysterectomy for the treatment of uterine fibroids.
The study will be conducted in the United Kingdom. Approximately 40 patients will receive treatment (either Vilaprisan or ulipristal acetate) for 8-12 weeks until their hysterectomy will take place (overall length of the study is approximately 20 weeks). For treated patients the study involves five scheduled visits at the study site and a follow-up visit or phone call.
The study will also include 15 patients who have not taken study drug (for comparison to the treated patients). For those untreated patients, the study involves two visits at the study site, a post-surgery follow-up and they will take part in the study for not usually more than a total of 12 weeks.
Study procedures include (but are not limited to) questionnaires, physical examinations, blood and urine sampling and endometrial biopsies. At the hysterectomy, tissue from all women participating will be collected from their removed womb.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0061
Date of REC Opinion
22 Jun 2017
REC opinion
Further Information Favourable Opinion