Mechanisms of Hormonal Control of Spermatogenesis in Man

University of Washington1 个研究点分布在 1 个国家开始时间: 2019年6月最近更新: 2019年12月18日

适应症

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方: University of Washington
试验地点: 1
主要终点: Sperm concentration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.

详细描述

This is a nine-month research study examining the effects on androgen treatment on sperm production in healthy men. There are three phase to the study, a 2-month screening phase, 4-month treatment and 3-month follow-up. In this study, the investigators aim to define a quantitative relationship between intra-testicular testosterone (IT-T) and spermatogenesis in man. Hormone levels will be measured in a small amount of testicular fluid at the beginning and end of treatment and sperm concentration will be measured.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
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 age 18-55
•In general good health based on normal screening evaluation
•Normal serum testosterone, lutenizing hormone (LH) and follicle stimulating hormone (FSH)
•Prostate Specific Antigen (PSA) < 3.0
•Agrees not to donate blood or participate in another research study during the study
•Informed consent
•Must be willing to use a reliable form of contraception during the study

排除标准

•Participation in a long-term male contraceptive study within the past three months
•History of testosterone or anabolic steroid abuse in the past
•History of or current skin disorder that will interfere with testosterone gel
•Poor general health or significantly abnormal screening blood results
•History of or current testicular or prostate disease
•History of a bleeding disorder or need for anticoagulation
•History of untreated sleep apnea and/or major psychiatric problems
•BMI > 32
•History of or current liver disease
•Chronic pain syndrome
•Current use of terfenidine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil
•Use of glucocorticoids or underlying adrenal insufficiency
•Active drug or alcohol abuse within the past year

研究组 & 干预措施

Acyline; T Gel; placebo dutasteride, placebo ketoconazole

Experimental

All men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned.

Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months

干预措施: Testosterone 1% Gel (Drug)

Acyline; T Gel; placebo dutasteride, placebo ketoconazole

Experimental

All men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned.

Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months

干预措施: Acyline (Drug)

Acyline; T Gel; placebo dutasteride, placebo ketoconazole

Experimental

All men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned.

Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months

干预措施: placebo dutasteride (Drug)

Acyline; T Gel; placebo dutasteride, placebo ketoconazole

Experimental

All men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned.

Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months

干预措施: placebo ketoconazole (Drug)