Oral T7 Oral Testosterone in Man

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

• Phase: Phase 2
• 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: Finasteride; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Males between 18 and 50 years of age

• In good health based on normal screening evaluation (consisting of a medical history, physical exam normal serum chemistry, hematology, and baseline hormone levels.

• Must agree to not participate in another research drug study

• Must agree to not donate blood

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

Exclusion Criteria:

• Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values)

• A known history of alcohol or drug abuse

• Participation in a long-term male contraceptive study within the past month

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

• History of sleep apnea

• History of major psychiatric disorder

• Body mass index > 37

• Infertility

• Hematocrit > 55 or < 30

• PSA >4