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

Allergan432 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

432

Conditions

Leiomyoma Uterine Hemorrhage

Interventions

Ulipristal acetate (UPA)DRUG

Ulipristal acetate (UPA) tablet.

PlaceboDRUG

Matching placebo tablet.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (63)

Outcomes

Primary Outcomes

Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1

Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.

Time frame: Last 35 consecutive days on treatment in the 12-Week Treatment Course 1

Time to Absence of Bleeding on Treatment During Treatment Course 1

Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.

Time frame: From first dose up to the end of the 12-Week Treatment Course 1

Secondary Outcomes

Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1

Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), from Day 11 to the end of treatment in Treatment Course 1.

Time frame: Day 11 through the end of treatment in the 12-Week Treatment Course 1

Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2

Time frame: Last 35 consecutive days on treatment in the 12-Week Treatment Course 2

Data from ClinicalTrials.gov

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Watson Investigational Site 138

Mesa, Arizona, United States

Watson Investigational Site 147

Phoenix, Arizona, United States

Watson Investigational Site 106

Scottsdale, Arizona, United States

Watson Investigational Site 124

Tucson, Arizona, United States

Watson Investigational Site 155

Little Rock, Arkansas, United States

Watson Investigational Site 155

Encino, California, United States

Watson Investigational Site 157

Hawaiian Gardens, California, United States

Watson Investigational Site 134

La Mesa, California, United States

Watson Investigational Site 127

San Diego, California, United States

Watson Investigational Site 151

San Diego, California, United States

...and 53 more locations

Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1

The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement.

Time frame: Baseline (Day 1-4) to End of 12-Week Treatment Course 1