Status:
COMPLETED
HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Healthy Males
Eligibility:
MALE
18-50 years
Phase:
PHASE1
PHASE2
Brief 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 devel...
Detailed Description
Three study drugs will be used in this study: Testim (testosterone gel), Human Chorionic Gonadotropin (hCG) and acyline. Testosterone is a naturally occurring hormone in men. When given to normal men,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00839319
Start Date
March 1 2009
End Date
November 1 2010
Last Update
January 11 2016
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195