drugset / Trial / NCT01215292

ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

Phase 1/2 Completed 46 enrolled University of Washington Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2011-01
Primary completion: 2012-03
Completion: 2012-03

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anastrozole	Other / unclassified	1 mg	Oral
Subject	Dutasteride	Small molecule	2.5 mg	Oral
Subject	Ketoconazole	Small molecule	400 mg	Oral
Subject	Ketoconazole	Small molecule	800 mg	Oral
Background	Acyline	Protein / enzyme biologic	300 ug/kg	—
Background	Testosterone gel	Unknown	5 g	Topical

Indications

No indication recorded.