At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Mechanisms of Control of the Intratesticular Hormonal Milieu in Man
In Brief
A Phase 2 clinical trial evaluating Acyline, Testosterone gel, and 5 other interventions for Healthy Males. Completed, enrolled 46 participants across 1 site.
Detailed Summary
The purpose of this research study is to determine how much male hormone, testosterone, is necessary to maintain sperm production in the testis. This knowledge will be used to help in the development of a safe male hormonal contraception. Specific Aims: 1. to determine if ketoconazole plus acyline will suppress intratesticular testosterone(ITT) to a greater degree than acyline alone. 2. to determine if dutasteride plus acyline will suppress intratesticular dihydrotestosterone (IT-DHT) to a greater degree than acyline alone. 3. to determine if anastrazole plus acyline will suppress intratesticular estradiol(IT-E2) to a greater degree than acyline alone.
Study Details
Timeline
Interventions
300 mcg/kg on Day 1
5 gm of 1% T Gel applied transdermally for 10 days
400 mg PO daily, Days 3-10
800 mg PO daily, Day 3-10
2.5 mg PO daily, Day 3-10
1 mg PO daily, Day 3-10
placebo to mimic ketoconazole