A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Phase 3

Completed

• Conditions: Leiomyoma; Uterine Hemorrhage
• Interventions: Drug: Ulipristal acetate (UPA); Drug: Placebo

• Registration Number: NCT02147197
• Lead Sponsor: Allergan

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

Not available

Study Timeline

• Study Start: 2014-03-31
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Primary Completion: 2016-03-29
• Study Completion: 2016-03-29
• Disposition First Submitted: 2017-03-16
• Disposition First Submitted QC: 2017-03-16
• Disposition First Posted: 2017-03-20
• Results First Submitted: 2019-03-15
• Results First Submitted QC: 2019-03-15
• Status Verified: 2019-04
• Results First Posted: 2019-04-05
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 157

Inclusion Criteria

• Pre-menopausal 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 rang

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UPA 5 mg	Ulipristal acetate (UPA)	Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
UPA 5 mg	Placebo	Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
UPA 10 mg	Placebo	UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
Placebo	Placebo	Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.
UPA 10 mg	Ulipristal acetate (UPA)	UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment	Last 35 consecutive days on treatment in the 12-week Treatment Period	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 the 12-week Treatment Period.
Time to Absence of Bleeding on Treatment	From first dose up to the end of the 12-week Treatment Period	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 on treatment. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose on treatment in the 12-week Treatment Period.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment	Day 11 through the end of the 12-week Treatment Period	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), starting from Day 11 through the end of the 12-week Treatment Period.
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 Period	Baseline (Day 1-4) to the end of 12-week Treatment Period	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.

Trial Locations

Locations (28)

Watson Investigational Site 103; 🇺🇸 Atlanta, Georgia, United States

Watson Investigational Site 115; 🇺🇸 Lakewood, Colorado, United States

Watson Investigational Site 111; 🇺🇸 Augusta, Georgia, United States

Watson Investigational Site 121; 🇺🇸 Raleigh, North Carolina, United States

Watson Investigational Site 101; 🇺🇸 Chattanooga, Tennessee, United States

Watson Investigational Site 113; 🇺🇸 Albuquerque, New Mexico, United States

Watson Investigational Site 114; 🇺🇸 Washington, District of Columbia, United States

Watson Investigational Site 124; 🇺🇸 Idaho Falls, Idaho, United States

Watson Investigational Site 125; 🇺🇸 Tucson, Arizona, United States

Watson Investigational Site 122; 🇺🇸 Lake Worth, Florida, United States

Watson Investigational Site 120; 🇺🇸 Orlando, Florida, United States

Watson Investigational Site 104; 🇺🇸 Orlando, Florida, United States

Watson Investigational Site 126; 🇺🇸 Memphis, Tennessee, United States

Watson Investigational Site 123; 🇺🇸 Atlanta, Georgia, United States

Watson Investigational Site 105; 🇺🇸 New Port Richey, Florida, United States

Watson Investigational Site 107; 🇺🇸 Columbus, Ohio, United States

Watson Investigational Site 129; 🇺🇸 Shawnee Mission, Kansas, United States

Watson Investigational Site 102; 🇺🇸 San Diego, California, United States

Watson Investigational Site 112; 🇺🇸 Denver, Colorado, United States

Watson Investigational Site 116; 🇺🇸 Milford, Connecticut, United States

Watson Investigational Site 130; 🇺🇸 Miami, Florida, United States

Watson Investigational Site 131; 🇺🇸 Brownsburg, Indiana, United States

Watson Investigational Site 110; 🇺🇸 Norfolk, Nebraska, United States

Watson Investigational Site 108; 🇺🇸 Myrtle Beach, South Carolina, United States

Watson Investigational Site 119; 🇺🇸 Jenkintown, Pennsylvania, United States

Watson Investigational Site 109; 🇺🇸 Winston-Salem, North Carolina, United States

Watson Investigational Site 106; 🇺🇸 Clearwater, Florida, United States

Watson Investigational Site 132; 🇺🇸 Metairie, Louisiana, United States