Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- The primary biological end points in this trial will be suppression of spermatogenesis and gonadotropins while monitoring for any adverse changes in lipid metabolism, sexual side effects or in general health
研究概览
简要总结
The purpose of this research study is to help in the development of male contraception (birth control).
详细描述
The objective is to conduct a male contraceptive trial in which we will evaluate the suppressive effects of acyline when administered in combination with Testosterone (T) and the progestin depo-medroxyprogesterone acetate (DMPA).
We will be administering combinations of three drugs: Testosterone (T) by gel, Depot Medroxyprogesterone acetate (DMPA) and Acyline to see their effects on sperm production. The T/DMPA/Acyline combination will allow us to determine if the more rapid and complete gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate and enhance suppression of spermatogenesis.
In prior studies with testosterone and DMPA these drug, which are hormones, have been found to be safe, and to reversibly suppress sperm counts to zero in about 80% of men. We hope to improve this to 100% of men by adding another drug, Acyline.
Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary. DMPA is approved by the FDA for use as a female contraceptive. The endpoint will be suppression of spermatogenesis to zero (azoospermia) by the end of the treatment phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males between 18-55
- •In good general health
- •With normal sperm counts
- •Willing to use an acceptable form of contraception
排除标准
- •Men in poor health
- •Significant chronic or acute medical illness
- •Skin conditions that might interfere with or be exacerbated by testosterone gel
- •Known history of alcohol, illicit drug or anabolic steroid abuse
- •Abnormal reproductive function
- •Participation in a long-term male contraceptive study within past three months
研究组 & 干预措施
1
Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
干预措施: Testosterone Gel (Drug)
1
Testosterone (T) gel for 6 months + DMPA (injected into muscle once)on Day 0 and at Month 3
干预措施: Depo-Medroxyprogesterone (Drug)
2
Testosterone (T) gel for 6 months + DMPA (injected into muscle on Day 0 & at month 3) + Acyline (SQ) every two weeks for the first 12 weeks
干预措施: Acyline (Drug)
2
Testosterone (T) gel for 6 months + DMPA (injected into muscle on Day 0 & at month 3) + Acyline (SQ) every two weeks for the first 12 weeks
干预措施: Testosterone Gel (Drug)
2
Testosterone (T) gel for 6 months + DMPA (injected into muscle on Day 0 & at month 3) + Acyline (SQ) every two weeks for the first 12 weeks
干预措施: Depo-Medroxyprogesterone (Drug)
结局指标
主要结局
The primary biological end points in this trial will be suppression of spermatogenesis and gonadotropins while monitoring for any adverse changes in lipid metabolism, sexual side effects or in general health
时间窗: One year
次要结局
- Regimen acceptability, sexual function, glucose tolerance, intratesticular hormone levels(One year)