Status:
COMPLETED
ITT4 Intratesticular Hormonal Milieu in Man (ITT4)
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 research 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 development ...
Detailed Description
Five drugs will be used in this study: acyline, testosterone gel, ketoconazole, dutasteride, and anastrazole. Acyline suppresses luteinizing hormone (LH) and follicle stimulating hormone (FSH), which...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males age 18-50
- Normal serum testosterone, LH and FSH
- prostate-specific antigen (PSA) \< 4.0
- Agrees not to donate blood or participate in another research study during the study
- Informed consent
- Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- In general good health based on normal screening evaluation (consisting of a medical history, physical exam, normal serum chemistry and hematology)
- Must be willing to use a reliable form of contraception during the study
- EXCLUSION CRITERIA:
- Poor general health, with clinically significant abnormal blood results
- Participation in a long-term male contraceptive study within the past three months
- Participation in long-term contraceptive or drug study within the past 3 months
- History of or current liver disease
- Current use of terfenadine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil
- History of testicular, prostate, or scrotal surgery/trauma or genital abnormal exam
- BMI \> 32
- History of sleep apnea and/or major psychiatric problems
- Chronic pain syndrome
- History of testosterone or anabolic steroid abuse currently or in the past
- Known bleeding disorder or current use of anticoagulation
- History of or current skin disorder that will interfere with testosterone gel
- Unwilling to adhere to protocol-stated restrictions while in the study
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01215292
Start Date
January 1 2011
End Date
March 1 2012
Last Update
March 31 2014
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195