A Two-part Trial Assessing the Effects of 7α-methyl-19-nortestosterone (MENT) on Blood Pressure in Normal Men: an Open-label Pilot Study Followed by a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To assess the effects of MENT gel on blood pressure as compared to placebo gel.
研究概览
简要总结
This is a two-part trial assessing the effects of MENT on blood pressure. The first part of the trial is an open-label pilot study to verify the MENT gel formulation delivers appropriate drug levels. Upon confirming MENT serum levels are within the required range, clinical trial material will be produced and labeled. Consequently, the second part of the trial, the main study, will proceed approximately two months after the conclusion of the pilot study. The main study, is a randomized, double-blind, placebo-controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men age 18-40
- •Man has a sperm concentration of greater than or equal to 15 x 106/mL at screening
- •Man has not used hormonal therapy in the last six months
- •Man has a testosterone level between 270-1070 ng/dL at screening
排除标准
- •Man is hypertensive, defined by
- •diastolic BP greater than or equal to 85 mmHg or systolic BP greater than or equal to 140 mmHg (the average of the 2nd and 3rd of 3 measurements after 10 minutes rest) at screening or
- •a baseline ABPM average of diastolic greater than or equal to 85 mmHg systolic greater than or equal to 130 mmHg or
- •is taking any hypertensive medication
- •Man has a BMI over 33 kg/m2
- •Man has active or a history of cerebrovascular or cardiovascular disease
- •Man has chronic or acute liver or renal disease
- •Man has a history of a significant psychiatric disorder, including severe depression
- •Man has dermatitis, psoriasis or other severe skin disorder
- •Man has clinically significant abnormalities of laboratory safety tests
研究组 & 干预措施
1
In the second part of the trial, subjects will apply MENT or placebo gel transdermally for 12 weeks and will have 24-hour blood pressure monitoring at baseline, Week 6 and Week 12.
干预措施: MENT or placebo (Drug)
结局指标
主要结局
To assess the effects of MENT gel on blood pressure as compared to placebo gel.
时间窗: 4 weeks
次要结局
- To evaluate the serum levels of MENT, testosterone, DHT, LH, FSH and estradiol and their variation under therapy(4 weeks)
- To assess the effects of MENT on sperm concentration(21 months)
- To evaluate the safety and tolerability of MENT.(21 months)