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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 432
- 试验地点
- 57
- 主要终点
- Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1
研究概览
简要总结
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
UPA 5 mg: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.
干预措施: Ulipristal acetate (UPA) (Drug)
UPA 5 mg: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.
干预措施: Placebo (Drug)
UPA 10 mg: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.
干预措施: Ulipristal acetate (UPA) (Drug)
UPA 10 mg: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.
干预措施: Placebo (Drug)
UPA 5 mg:UPA 5 mg
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.
干预措施: Ulipristal acetate (UPA) (Drug)
UPA 5 mg:UPA 5 mg
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.
干预措施: Placebo (Drug)
UPA 10 mg:UPA 10 mg
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.
干预措施: Ulipristal acetate (UPA) (Drug)
UPA 10 mg:UPA 10 mg
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.
干预措施: Placebo (Drug)
Placebo:UPA 5 mg
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.
干预措施: Ulipristal acetate (UPA) (Drug)
Placebo:UPA 5 mg
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.
干预措施: Placebo (Drug)
Placebo:UPA 10 mg
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.
干预措施: Ulipristal acetate (UPA) (Drug)
Placebo:UPA 10 mg
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)