ORAL T-8 Oral Testosterone for Male Hormonal Contraception (Oral T-8)
Recruitment status was Active, not recruiting
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men With Experimental Hypogonadism|
- To test how the body absorbs a new form of oral testosterone. [ Time Frame: 2 month period ] [ Designated as safety issue: Yes ]Volunteers will be asked to come to the University of Washington Medicine Center, about 6 visits including two overnight stays (24 hr each) during the drug phase.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||November 2011|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Drug: Acyline and Oral Testosterone
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.
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||John K Amory, MD||University of Washington|