Status:
COMPLETED
ORAL T-8 Oral Testosterone for Male Hormonal Contraception
Lead Sponsor:
University of Washington
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of...
Detailed Description
We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will be given on Day 0 to turn off the body's testosterone production for about 10-14 days. The next day, Day 1...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- able and willing to
- not participate in another drug study or donate blood, not take medications
- use contraception, comply with the protocol
- EXCLUSION CRITERIA:
- abnormal evaluation, based on physical exam, medical history, blood tests (including serum chemistry, hematology, HIV, HCV, hormone levels)
- history or current use of alcohol, drug, steroid abuse, \>3 alcohol drinks/day
- history of testicular disease, severe testicular trauma, major psychiatric disorder, bleeding disorders, current use of anti-coagulants or testosterone
- participation in hormonal drug study within past month
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01167829
Start Date
July 1 2010
End Date
June 1 2012
Last Update
September 6 2013
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195