NCT01631981已完成2 期
A Phase II, Multicentre, Randomised, Two-Arm, Parallel Group, Double-Blind, Placebo Controlled Study of the Steroid Sulfatase Inhibitor PGL2001 With Concomitant Administration of NETA (Norethisterone Acetate) for the Treatment of Symptoms Related to Endometriosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PregLem SA
- 入组人数
- 162
- 试验地点
- 20
- 主要终点
- Non-menstrual pelvic pain.
研究概览
简要总结
This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration for the treatment of pain symptoms suggestive of endometriosis. The target population will be women of reproductive age with symptoms suggestive of endometriosis.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent prior to initiation of any study related procedures.
- •Be a woman of reproductive age between 18 and 45 years inclusive.
- •Present with clinical signs suggestive of endometriosis.
- •Be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit.
排除标准
- •Be pregnant or currently lactating.
- •Have diseases or suspected diseases which may cause pelvic pain not due to endometriosis.
- •Have had any surgical treatment for endometriosis within the last 12 months.
- •Have documented significant adenomyosis.
- •Have participated in another clinical trial within the 30 days prior to the screening visit.
研究组 & 干预措施
PGL2001
Experimental
PGL2001 + NETA followed by NETA-only follow-up period
干预措施: PGL2001 + Primolut-Nor 5 (Drug)
Placebo
Placebo Comparator
Placebo + NETA followed by NETA-only follow-up period
干预措施: Placebo + Primolut-Nor 5 (Drug)
结局指标
主要结局
Non-menstrual pelvic pain.
时间窗: Daily collection up to 16 weeks
Use of a Visual Analogue Scale (VAS).
次要结局
未报告次要终点
研究者
研究点 (20)
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