ORAL T-8 Oral Testosterone for Male Hormonal Contraception (Oral T8)

University of Washington

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oral Testosterone; Drug: Acyline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01167829

38636-D

Details and patient eligibility

About

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.

Full description

We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will be given on Day 0 to turn off the body's testosterone production for about 10-14 days.

The next day, Day 1, subjects begin taking 300 mg modified slow-release testosterone pill by mouth, three times a day, around 9 AM, 1 PM, and 7 PM for a total of 27 pills.

There are overnight stays on Day 1 and Day 9 to allow monitoring of blood testosterone levels over a 24 hour period, from @9 AM to 9 AM the next morning. At those visits, blood is drawn at baseline (before taking the pill) and at 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 16, and 24 hours after the morning dose.

Acyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. We have used acyline in over 125 men without serious side effects. The use of testosterone in this study is experimental and there may be unknown or unanticipated risks.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Acyline and oral testosterone

Experimental group

Treatment:

Drug: Oral Testosterone

Drug: Acyline