A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

• Status: Completed
• Trial end date: 2016-11-24
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan; Watson Pharmaceuticals
• Treatments: Ulipristal acetate

Criteria

Inclusion Criteria:

• Premenopausal women, 18-50 years, inclusive.

• Cyclic abnormal uterine bleeding (heavy or prolonged).

• Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.

• Minimum of one discrete leiomyoma observable by transvaginal ultrasound.

• Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia.

Exclusion Criteria:

• History of uterine surgery that would interfere with the study endpoints.

• Known coagulation disorder including bleeding disorder or clotting disorder.

• History of, or current uterine, cervix, ovarian, or breast cancer.

• Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal range.