PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The investigators will conduct a three-month, randomized, placebo-controlled trial comparing the effects of increasing doses of androgen supplementation with Testosterone (T) gel on the prostate in healthy men who are treated with acyline to block gonadal androgen production.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborators: National Institute on Aging (NIA); National Institutes of Health (NIH)
• Treatments: Acyline; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

In good health, without severe systemic illness (i.e., renal, liver, cardiac or lung disease, cancer, insulin dependent diabetes)

• Male between the ages of 25 and 55 years old

• Able to understand and comply with protocol instructions and requirements

• International Prostate Symptom Score (IPSS) <11

• Agrees to not donate blood during the study

• Normal serum total T, LH, FSH, urine analysis, COMP, CBC and sperm count

Exclusion Criteria:

• History of, or current breast cancer or prostate cancer

• Clinically significant findings on digital rectal exam such as nodules, areas of induration or any other malignancy or abnormal prostate ultrasound

• History of invasive therapy for BPH

• Current or past treatment with a 5α-reductase inhibitor

• History of drug or alcohol abuse within the past 12 months

• History of a bleeding disorder or anticoagulation

• Skin disease that might interfere with T-gel absorption

• Participation in another drug study in the past 3 months

• A first-degree relative (i.e. father, brother) with a history of prostate cancer

• History of infertility or desire for fertility within 6 months, or current pregnant female partner

• Weight >320 pounds or BMI > 40

• PSA Level > 2.1