A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
- Conditions
- Uterine HemorrhageLeiomyoma
- Interventions
- 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
- 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.
- 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 108
🇺🇸Las Vegas, Nevada, United States
Watson Investigational Site 107
🇺🇸Las Vegas, Nevada, United States
Watson investigational site 142
🇺🇸Pittsburgh, Pennsylvania, United States
Watson Investigational Site 109
🇺🇸Houston, Texas, United States
Watson Investigational Site 124
🇺🇸Tucson, Arizona, United States
Watson Investigational Site 155
🇺🇸Houston, Texas, United States
Watson Investigational Site 157
🇺🇸Hawaiian Gardens, California, United States
Watson Investigational Site 134
🇺🇸La Mesa, California, United States
Watson Investigational Site 131
🇺🇸Clearwater, Florida, United States
Watson Investigational Site 102
🇺🇸Wellington, Florida, United States
Watson Investigational Site 123
🇺🇸Plantation, Florida, United States
Watson Investigational Site 112
🇺🇸Sarasota, Florida, United States
Watson Investigational Site 101
🇺🇸West Palm Beach, Florida, United States
Watson Investigational Site 103
🇺🇸Sandy Springs, Georgia, United States
Watson Investigational Site 160
🇺🇸Atlanta, Georgia, United States
Watson Investigational Site 117
🇺🇸Savannah, Georgia, United States
Watson Investigational Site 113
🇺🇸Champaign, Illinois, United States
Watson Investigational Site 119
🇺🇸Schaumburg, Illinois, United States
Watson Investigational Site 162
🇺🇸Brownsburg, Indiana, United States
Watson Investigational Site 104
🇺🇸Granger, Indiana, United States
Watson Investigational Site 150
🇺🇸Covington, Louisiana, United States
Watson Investigational Site 130
🇺🇸Metairie, Louisiana, United States
Watson Investigational Site 116
🇺🇸New Orleans, Louisiana, United States
Watson Investigational Site 111
🇺🇸Lawrenceville, New Jersey, United States
Watson Investigational Site 158
🇺🇸Moorestown, New Jersey, United States
Watson Investigational Site 115
🇺🇸Albuquerque, New Mexico, United States
Watson Investigational Site 128
🇺🇸Greensboro, North Carolina, United States
Watson Investigational Site 145
🇺🇸New Bern, North Carolina, United States
Watson Investigational Site 146
🇺🇸Raleigh, North Carolina, United States
Watson Investigational Site 118
🇺🇸Winston-Salem, North Carolina, United States
Watson Investigational Site 139
🇺🇸Englewood, Ohio, United States
Watson Investigational Site 133
🇺🇸Philadelphia, Pennsylvania, United States
Watson Investigational Site 148
🇺🇸Cleveland, Ohio, United States
Watson Investigational Site 105
🇺🇸West Reading, Pennsylvania, United States
Watson Investigational Site 136
🇺🇸Bluffton, South Carolina, United States
Watson Investigational Site 153
🇺🇸Columbia, South Carolina, United States
Watson Investigational Site 110
🇺🇸Charleston, South Carolina, United States
Watson Investigational Site 154
🇺🇸Greenville, South Carolina, United States
Watson Investigational Site 122
🇺🇸Dallas, Texas, United States
Watson Investigational Site 114
🇺🇸Frisco, Texas, United States
Watson Investigational Site 129
🇺🇸Webster, Texas, United States
Watson Investigational Site 152
🇺🇸Norfolk, Virginia, United States
Watson Investigational Site 137
🇺🇸Virginia Beach, Virginia, United States
Watson Investigational Site 140
🇨🇦Hamilton, Ontario, Canada
Watson Investigational Site 144
🇨🇦Ottawa, Ontario, Canada
Watson Investigational Site 121
🇺🇸Seattle, Washington, United States
Watson Investigational Site 127
🇺🇸San Diego, California, United States
Watson Investigational Site 151
🇺🇸San Diego, California, United States
Watson Investigational Site 126
🇺🇸Durham, North Carolina, United States
Watson Investigational Site 120
🇺🇸San Antonio, Texas, United States
Watson Investigational Site 159
🇺🇸Denver, Colorado, United States
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 135
🇺🇸Miramar, Florida, United States
Watson Investigational Site 132
🇺🇸North Miami, Florida, United States
Watson Investigational Site 161
🇺🇸Orlando, Florida, United States