NCT02323646已完成2 期
A Phase 2, Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Percentage of Participants in Amenorrhea at the End of Treatment Course 1
研究概览
简要总结
The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 47 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females between 18 and 47 years.
- •Have a history of at least 3 regular menstrual cycles in which menorrhagia is due to uterine fibroids.
- •Must have uterine fibroids.
- •Agreement not to attempt to become pregnant during the trial.
- •Agreement to use only sanitary pads provided throughout the course of the study, tampon use is prohibited .
- •Ability to complete a daily Participant diary and study procedures in compliance with the protocol.
- •Have a negative pregnancy test at the Screening and Baseline visits, and subsequent study visits.
- •A Body Mass Index (BMI) between 18 and 45 inclusive.
- •Menstrual blood loss > 80 milliliters (mL) by alkaline hematin assay.
排除标准
- •Post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy.
- •Pregnant or lactating or is attempting or expecting to become pregnant during the entire study period.
- •Received an investigational drug in the 30 days prior to the screening for this study.
- •History of Polycystic Ovarian Syndrome (PCOS).
- •Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, Dihydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to screening and during the study.
- •Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 10 months.
- •Use of Gonadotropin Releasing Hormone (GnRHas) (e.g. Lupron Depot) within 3 months of the first dose of study drug (Lupron Depot must have a wash-out period of 3 months).
- •Has an Intra Uterine device (IUD) in place.
- •Known or suspected carcinoma of the breast or reproductive organs.
- •Recent history (within past 6 months) of alcoholism or drug abuse.
- •Clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
干预措施: Placebo (Drug)
Telapristone Acetate 6 mg
Experimental
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
干预措施: Telapristone Acetate (Drug)
Telapristone Acetate 12 mg
Experimental
Following the baseline assessment no treatment period, telapristone acetate 12mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
干预措施: Telapristone Acetate (Drug)
结局指标
主要结局
Percentage of Participants in Amenorrhea at the End of Treatment Course 1
时间窗: At the end of 18-weeks Treatment Course 1
Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score \>1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.
次要结局
- Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit)
- Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit)
- Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2)
- Percentage of Participants in Amenorrhea at the End of Treatment Course 2(At the end of 18-weeks Treatment Course 2)
- Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit)
- Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit)
- Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit)
- Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit)
- Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit)
- Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit)
- Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit)
- Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2(Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2)
研究者
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