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

Phase 3

Completed

Conditions: Uterine Hemorrhage
Leiomyoma

Interventions: Drug: Ulipristal acetate (UPA)
Drug: Placebo

Registration Number: NCT02147158

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 432

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UPA 10 mg:UPA 10 mg	Ulipristal acetate (UPA)	UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
UPA 5 mg:Placebo	Ulipristal acetate (UPA)	Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
UPA 5 mg:UPA 5 mg	Ulipristal acetate (UPA)	UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
Placebo:UPA 10 mg	Placebo	Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
UPA 5 mg:UPA 5 mg	Placebo	UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
UPA 5 mg:Placebo	Placebo	Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
UPA 10 mg:Placebo	Ulipristal acetate (UPA)	UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
UPA 10 mg:Placebo	Placebo	UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
UPA 10 mg:UPA 10 mg	Placebo	UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
Placebo:UPA 5 mg	Placebo	Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
Placebo:UPA 5 mg	Ulipristal acetate (UPA)	Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
Placebo:UPA 10 mg	Ulipristal acetate (UPA)	Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1	Last 35 consecutive days on treatment in the 12-Week 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 to Absence of Bleeding on Treatment During Treatment Course 1	From first dose up to the end of the 12-Week 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1	Day 11 through the end of treatment in the 12-Week 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.
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2	Last 35 consecutive days on treatment in the 12-Week Treatment Course 2	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 2.
Time to Absence of Bleeding on Treatment During Treatment Course 2	From first dose up to the end of treatment in the 12-Week Treatment Course 2	Time to absence of bleeding is defined as the duration in days from first dose in treatment course 2 to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the second 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 2.
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	Baseline (Day 1-4) to End of 12-Week 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.

Trial Locations

Locations (57): Watson Investigational Site 138
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Mesa, Arizona, United States
Watson Investigational Site 147
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Phoenix, Arizona, United States
Watson Investigational Site 106
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Scottsdale, Arizona, United States
Watson Investigational Site 124
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Tucson, Arizona, United States
Watson Investigational Site 155
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Houston, Texas, United States
Watson Investigational Site 157
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Hawaiian Gardens, California, United States
Watson Investigational Site 134
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La Mesa, California, United States
Watson Investigational Site 127
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San Diego, California, United States
Watson Investigational Site 151
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San Diego, California, United States
Watson Investigational Site 159
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Denver, Colorado, United States
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Watson Investigational Site 138
🇺🇸Mesa, Arizona, United States