A Single Dose lead-in PK Followed by a Randomized, Double-blinded, Controlled, Multiple Dose Study of the Selective Progesterone Receptor Modulator Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
研究概览
简要总结
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
详细描述
Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound.
- •Had a regular or steady menstrual cycle lasting from 24 to 36 days.
排除标准
- •Post-menopausal
- •Subject with documented endometriosis
研究组 & 干预措施
progenta 12.5 mg
Progenta (CDB-4124) 12.5 mg capsule
干预措施: Progenta (Drug)
progenta 25 mg
Progenta (CDB-4124) 25 mg capsule
干预措施: Progenta (Drug)
progenta 50 mg
Progenta (CDB-4124) 50 mg capsule
干预措施: Progenta (Drug)
Lucron Depot
Lucron Depot, Leuprolide acetate for depot suspension
干预措施: Lucron Depot (Drug)
placebo
Placebo capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
时间窗: 90 days
次要结局
- Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata.(90 days)