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Adenomyosis and Ulipristal Acetate — FRA-IIT-UPA  

Adenomyosis Clinical Trial

Official title:
Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis

Clinical Trial Summary

Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.

Clinical Trial Description

After inclusion according to criteria, 2 arms : placebo and Ulipristal acetate (UA) 10mg with randomisation, 1 patient with placebo for 3 patients with UA. 48 patients will be included in this trial. The end point will be the bleeding evaluated by Pictorial Blood-loss Assessment Chart (PBAC) score, the amenorrhea rate and the pain evaluated with visual analogic scale. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02587000
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 2
Start date June 16, 2015
Completion date March 17, 2020
View Details
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