A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of Spermatogenesis Suppression After Oral Administration of Dimethandrolone Undecanote (DMAU) Alone or With Levonorgestrel (LNG) for 12 Weeks Versus Placebo Alone in Normal Men
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Suppression of spermatogenesis as assessed by semen analyses using number of subjects with sperm concentration <3 million (M)/mL with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.
研究概览
简要总结
This is a Phase IIa multicenter, double-blind, placebo-controlled study in healthy men to evaluate the spermatogenesis suppression after oral administration of Dimethandrolone Undecanoate (DMAU) alone or with Levonorgestrel (LNG) for 12 weeks versus placebo alone.
详细描述
This 12 week repeated dose study will be conducted at two centers: the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the University of Washington. The sites propose to enroll approximately 100 men with a goal of enrolling 20 healthy male subjects in each of the 4 active groups and 20 in the placebo group for 12 weeks of treatment. The goal is to complete at least 17 efficacy evaluable subjects in each group. The DMAU for this study will be castor oil formulation administered after a 25 to 30 g fat meal. The oral dose of LNG will be 30 mcg per day. The study volunteers will be randomized to one of five treatment groups:
Group 1: Lower DMAU dose (100 mg per day) + LNG (30 mcg per day) (n=20) Group 2: Middle DMAU dose (200mg per day) + LNG (30 mcg per day) (n=20) Group 3: Middle DMAU dose (200 mg per day) + placebo LNG (n=20) Group 4: Higher DMAU dose (400 mg per day) + placebo LNG (n=20) Group 5: Placebo DMAU capsules and placebo LNG capsules (n=20)
Each treatment group will receive the identical number of capsules in blinded fashion so that each subject will receive an identical number of capsules in order to maintain the blind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lower DMAU + LNG
DMAU 100 mg + LNG 30 mcg administered orally in capsules.
干预措施: Dimethandrolone-Undecanoate (Drug)
Lower DMAU + LNG
DMAU 100 mg + LNG 30 mcg administered orally in capsules.
干预措施: Levonorgestrel 0.03 MG (Drug)
Middle DMAU + LNG
DMAU 200 mg + LNG 30 mcg administered orally in capsules.
干预措施: Dimethandrolone-Undecanoate (Drug)
Middle DMAU + LNG
DMAU 200 mg + LNG 30 mcg administered orally in capsules.
干预措施: Levonorgestrel 0.03 MG (Drug)
Middle DMAU + Placebo
DMAU 200 mg + placebo administered orally in capsules.
干预措施: Dimethandrolone-Undecanoate (Drug)
Middle DMAU + Placebo
DMAU 200 mg + placebo administered orally in capsules.
干预措施: Placebo oral capsule (Drug)
Higher DMAU + Placebo
DMAU 400 mg + placebo administered orally in capsules.
干预措施: Dimethandrolone-Undecanoate (Drug)
Higher DMAU + Placebo
DMAU 400 mg + placebo administered orally in capsules.
干预措施: Placebo oral capsule (Drug)
Placebo
Placebo administered orally capsules.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Suppression of spermatogenesis as assessed by semen analyses using number of subjects with sperm concentration <3 million (M)/mL with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.
时间窗: 12 weeks
次要结局
- Changes from baseline in weight.(4 - 6 months)
- Changes from baseline in blood pressure.(4 - 6 months)
- Changes from baseline in heart rate.(4 - 6 months)
- Changes from baseline in PSA with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in sperm concentration.(4 - 6 months)
- Changes from baseline in blood urea nitrogen with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in Estradiol level.(4 - 6 months)
- Changes from baseline in DHT level.(4 - 6 months)
- Changes from baseline in LNG level.(4 - 6 months)
- Incidence of treatment emergent adverse events (safety and tolerability) with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in potassium with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in creatinine with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in calcium with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in DMA level.(4 - 6 months)
- Changes from baseline in sodium with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in bicarbonate with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in chloride with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Assessing suppression of gonadotropins using percentage of subjects with FSH and LH ≤ 1.0 IU/L.(2 months)
- Changes from baseline in LH level.(4 - 6 months)
- Changes from baseline in FSH level.(4 - 6 months)
- Changes from baseline in Testosterone level.(4 - 6 months)
- Changes from baseline in SHBG level.(4 - 6 months)
- Changes from baseline in DMAU level.(4 - 6 months)
- Changes from baseline in total bilirubin with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in fasting glucose with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in prostate function with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone using the International Prostate Symptom Score.(12 weeks)
- Changes from baseline in mood with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone using the Patient Health Questionnaire-9.(12 weeks)
- Changes from baseline in alkaline phosphatase with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in alanine aminotransferase with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in aspartate transaminase with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in albumin with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone.(12 weeks)
- Changes from baseline in sexual function with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone using the psychosexual daily questionnaire.(12 weeks)