Phase 2 N=40 Randomized Single-blind Treatment

ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

Healthy Males

Bottom Line

View on ClinicalTrials.gov: NCT01215292 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Jan 2014

Primary outcome: Primary: Intratesticular Testosterone (IT-T) Level — 14; 3.7; 1.7; 18.4 ng/mL — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acyline (Drug); Testosterone gel (Drug); ketoconazole 400 (Drug); Ketoconazole 800 (Drug); Dutasteride (Drug); Anastrozole (Drug); Placebo ketoconazole (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: University of Washington
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Intratesticular Testosterone (IT-T) Level	14; 3.7; 1.7; 18.4; 24.0	<0.05 sig
PRIMARY Intratesticular Dihydrotestosterone (DHT) Level	3.17; 2.08; 1.46; 0.12; 3.63	<0.05 sig
PRIMARY Intratesticular Androstenedione (ADD) Level	.87; 0.5; 0.12; 1.7; 3.6	<0.05 sig

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.

Eligibility Criteria

INCLUSION CRITERIA

Males age 18-50
Normal serum testosterone, LH and FSH
prostate-specific antigen (PSA) 32
History of sleep apnea and/or major psychiatric problems
Chronic pain syndrome
History of testosterone or anabolic steroid abuse currently or in the past
Known bleeding disorder or current use of anticoagulation
History of or current skin disorder that will interfere with testosterone gel
Unwilling to adhere to protocol-stated restrictions while in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01215292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.