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HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone

NCT00839319 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-01-11

Study results available
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Summary

The purpose of this investigational 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.

Conditions

  • Healthy Males

Interventions

DRUG

Acyline

300 ug/kg subcutaneous injections on Day 1.

OTHER

placebo hCG (no active ingredient)

placebo hCG

DRUG

hCG (human chorionic gonadotropin)

15 IU subcutaneous injection every other day for 10 days (5 doses)

DRUG

hCG (human chorionic gonadotropin)

60 IU subcutaneous injection

DRUG

hCG (human chorionic gonadotropin)

125 IU subcutaneous injection

DRUG

Testosterone gel

75 mg testosterone gel applied transdermally for 10 days

Sponsors & Collaborators

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

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • William Bremner, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-09-30
Completion
2010-11-30

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 NCT00839319 on ClinicalTrials.gov