Oral Androgens in Man-4: (Short Title: Oral T-4)
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Contraception
In brief
The protocol was designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In addition, we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in the normal range throughout the day, with the same dose (800 mg once daily) administered once daily. This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval
Key facts
- Study ID
- NCT00399165
- Run by
- University of Washington
- People needed
- 20
- Starts
- 2006-11-01
- Expected to finish
- 2007-05-01
- Last updated by the study team
- 2008-09-22
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Males between 18 to 55 years of age
- In good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal serum chemistry, hematology, and baseline hormone levels)
- Subject must agree not to participate in another research drug study for the duration of the study
- Subject must agree to not donate blood during the study
- Subject must be willing to comply with the study protocol and procedures
You may not qualify if…
- Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values)
- A known history of alcohol or drug abuse
- A history of testicular disease or severe testicular trauma,
- A history of bleeding disorders or current use of anti-coagulants
- A history of sleep apnea and/or major psychiatric disorders
- A body-mass index greater than 35,
- A history of or current use of testosterone
- Infertility
Where it is running
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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