Conditions: Leiomyoma Uterine Hemorrhage
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 157
Healthy volunteers: no

Brief summary:
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

Detailed description:

Arms:
arm 1: Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks. arm 2: UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks. arm 3: Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.

Interventions: intervention 1: Ulipristal acetate (UPA) intervention 2: Placebo
Intervention descriptions: intervention 1: UPA tablet intervention 2: Matching placebo tablet.

Protocol document: