ORAL T-8 Oral Testosterone for Male Hormonal Contraception

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Oral Testosterone; Drug: Acyline

• Registration Number: NCT01167829
• Lead Sponsor: University of Washington

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2010-10
• Study Completion: 2012-06
• Results First Submitted: 2012-09-25
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-21
• Results First Posted: 2013-08-23
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acyline and oral testosterone	Oral Testosterone	-
Acyline and oral testosterone	Acyline	-

Primary Outcome Measures

Name	Time	Method
Maximum Testosterone Concentration	baseline & day 9	initial pharmacokinetics \[PK\] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment
Mean Testosterone Concentration	baseline & day 9	initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment

Secondary Outcome Measures

Name	Time	Method
Maximum Dihydrotestosterone (DHT) Concentration	baseline & day 9
Mean Dihydrotestosterone (DHT) Concentration	baseline & day 9
Maximum Sex Hormone-Binding Globulin (SHGB)Concentration	baseline & day 9
Mean SHGB Concentration	baseline & day 9
Maximum Estradiol Concentration	baseline & day 9
Mean Estradiol Concentration	baseline & day 9
Free T Maximum Concentration	baseline & day 9	Free T normal range 4.7-18 ng/dL
Free Testosterone Mean Concentration	baseline & day 9	Free T normal range 4.7-18 ng/dL

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States