Overview

This trial is active, not recruiting.

Condition uterine bleeding in women with leiomyomas
Treatments ulipristal acetate (upa) 5 mg, ulipristal acetate (upa) 10 mg, placebo
Phase phase 3
Sponsor Watson Pharmaceuticals
Start date January 2014
End date November 2016
Trial size 432 participants
Trial identifier NCT02147158, UL1208

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Placebo followed by UPA 5 mg
ulipristal acetate (upa) 5 mg
placebo
(Experimental)
Placebo followed by UPA 10 mg
ulipristal acetate (upa) 10 mg
placebo
(Experimental)
UPA 5 mg followed by UPA 5 mg
ulipristal acetate (upa) 5 mg
(Experimental)
UPA 5 mg followed by Placebo
ulipristal acetate (upa) 5 mg
placebo
(Experimental)
UPA 10 mg followed by UPA 10 mg
ulipristal acetate (upa) 10 mg
(Experimental)
UPA 10 mg followed by Placebo
ulipristal acetate (upa) 10 mg
placebo

Primary Outcomes

Measure
Absence of bleeding
time frame: 12 weeks
Time to absence of bleeding
time frame: 12 weeks

Eligibility Criteria

Female participants from 18 years up to 50 years old.

Inclusion Criteria: - Cyclic abnormal uterine bleeding (heavy or prolonged). - Menstrual blood loss (MBL) of ≥ 80 mL in the first 8 days of menses. - Minimum of one discrete leiomyoma observable by transvaginal ultrasound. Exclusion Criteria: - Evidence of malignancy or atypical or non-atypical hyperplasia on endometrial biopsy.

Additional Information

Official title A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Watson Pharmaceuticals.