ORAL T-6: Oral Androgens in Man-6

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Treatments: Acyline; Androgens; Finasteride; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• males between 18 to 50 years of age in good general health based on normal screening evaluation

• must agree not to participate in another research drug study during participation

• must agree to not donate blood during the study

• must be willing to comply with the study protocol and procedures

• must agree to use an acceptable form of contraception

• agrees to not take medications other than the study drugs for the duration of the study

Exclusion Criteria:

• Subject in poor health, determined by medical history physical and lab results

• a known history or current use of alcohol, drug or steroid abuse and/or use of more than 3 alcohol beverages per day

• Participation in a long-term contraceptive study within the past two months

• History of bleeding disorders or current use of anti-coagulants

• History of sleep apnea and/or major psychiatric disorders