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ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

NCT01215292 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2014-03-31

Study results available
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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.

Conditions

  • Healthy Males

Interventions

DRUG

Acyline

300 mcg/kg on Day 1

DRUG

Testosterone gel

5 gm of 1% T Gel applied transdermally for 10 days

DRUG

ketoconazole 400

400 mg PO daily, Days 3-10

DRUG

Ketoconazole 800

800 mg PO daily, Day 3-10

DRUG

Dutasteride

2.5 mg PO daily, Day 3-10

DRUG

Anastrozole

1 mg PO daily, Day 3-10

DRUG

Placebo ketoconazole

placebo to mimic ketoconazole

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Mara Y Roth, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01215292 on ClinicalTrials.gov