Trials / Completed
CompletedNCT02587000
Adenomyosis and Ulipristal Acetate
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- Female
- Age
- 30 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ulipristal acetate | |
| DRUG | Placebo |
Timeline
- Start date
- 2015-06-16
- Primary completion
- 2018-02-02
- Completion
- 2020-03-17
- First posted
- 2015-10-27
- Last updated
- 2022-09-27
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02587000. Inclusion in this directory is not an endorsement.