Status:
COMPLETED
Oral T7 Oral Testosterone in Man
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Healthy Males
Male Contraceptive
Eligibility:
MALE
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the...
Detailed Description
We will be using three drugs: The first, acyline, temporarily turns off the body's production of testosterone for about two weeks. Subjects will receive acyline as shots three times over a six-week dr...
Eligibility Criteria
Inclusion
- Males between 18 and 50 years of age
- In good health based on normal screening evaluation (consisting of a medical history, physical exam normal serum chemistry, hematology, and baseline hormone levels.
- Must agree to not participate in another research drug study
- Must agree to not donate blood
- Must be willing to comply with the study protocol and procedures
Exclusion
- Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values)
- A known history of alcohol or drug abuse
- Participation in a long-term male contraceptive study within the past month
- History of bleeding disorders or current use of anti-coagulants
- History of sleep apnea
- History of major psychiatric disorder
- Body mass index \> 37
- Infertility
- Hematocrit \> 55 or \< 30
- PSA \>4
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00842751
Start Date
July 1 2009
End Date
December 1 2009
Last Update
January 13 2014
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195