Status:
COMPLETED
Oral Androgens in Man-4: (Short Title: Oral T-4)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Contraception
Eligibility:
MALE
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
This study will be carried out in a double-blinded fashion, so neither the subject nor the investigator will be aware of treatment assignment during the study. This protocol is designed to address the...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00399165
Start Date
November 1 2006
End Date
May 1 2007
Last Update
September 22 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Washington
Seattle, Washington, United States, 98195