NCT01016340终止2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia (MCS_MOS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To compare changes in total motile sperm (TMS) between groups from baseline to 16 weeks after treatment
研究概览
简要总结
This is a phase II randomized, double-blind, placebo-controlled study where eligible subfertile male subjects (age 20 years).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects who are 20 years old or older
- •Subjects who are diagnosed as idiopathic oligoasthenospermia
- •Subjects who have a normal baseline hormone profile
- •Subjects who were not able to impregnate female partners in the past 12 months under an active and unprotected sexual life
- •Subject's female partner has no endocrine or genital obstructive disorders and is capable of impregnation.
- •Subjects who have an acceptable baseline liver function
- •Subjects who have a normal baseline renal function.
排除标准
- •Subjects who have been diagnosed as male infertility for more than 5 years.
- •Subjects who have a baseline semen white blood cell count of 1*106/mL.
- •Subjects who have genital/seminal tract obstruction, infection, inflammation or anatomic abnormalities.
- •Subjects whose female partner has been diagnosed as infertility of any kind.
- •Male infertility that is associated with hormonal deficiency/imbalance, poor nutrition, congenital/chromosomal disorders, erectile dysfunction, or psychological disorders.
- •Subjects who plan to undergo artificial insemination of any kind within the study period.
- •Subjects who have been treated with chemotherapy, pelvic irradiation or major pelvic surgery
- •Subjects who will undergo any invasive procedures within the study period
- •Subjects who will undergo any chemotherapy or radiotherapy of any kind during the study period.
- •Subjects who can not or are not willing to undergo the two-week wash-out period for any reasons.
研究组 & 干预措施
MCS-5
Active Comparator
Group 1: MCS-5 5 mg/day for 16 weeks;Group 2: MCS-5 10 mg/day for 16 weeks;Group 3: MCS-5 20 mg/day for 16 weeks
干预措施: MCS (Drug)
Placebo
Placebo Comparator
Group 4: Placebo for 16 weeks
干预措施: MCS (Drug)
结局指标
主要结局
To compare changes in total motile sperm (TMS) between groups from baseline to 16 weeks after treatment
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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