ORAL T-8 Oral Testosterone for Male Hormonal Contraception

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

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 Washington to monitor blood testosterone levels over a 24-hour period.

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

Details

• Lead Sponsor: University of Washington
• Collaborator: GlaxoSmithKline
• Treatments: Acyline; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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