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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Healthy Males

In brief

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.

Key facts

Study ID: NCT00839319
Run by: University of Washington
People needed: 59
Starts: 2009-03-01
Expected to finish: 2010-11-01
Last updated by the study team: 2016-01-11

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Males age 18-50
Normal serum testosterone, LH and FSH
PSA < 4.0
Agrees not to donate blood or participate in another research study during the study
Informed consent
In general good health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry and hematology)
Must be willing to use a reliable form of contraception during the study

You may not qualify if…

Oligospermia (sperm count < 15 million/mL after 48 hours of abstinence) and/or abnormal motility or morphology.
Participation in a long-term male contraceptive study within the past three months
History of testosterone or anabolic steroid abuse in the past
Poor general health with significantly abnormal blood results
History of or current testicular disease
History of a bleeding disorder or need for anticoagulation
History of sleep apnea and/or major psychiatric problems
BMI > 32
Subjects with a skin condition that might interfere or be exacerbated by testosterone gel use
Subject's with alcohol or drug use

Where it is running

University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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