ORAL T-8 Oral Testosterone for Male Hormonal Contraception

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men With Experimental Hypogonadism

Conditions
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Healthy

Intervention / Treatment
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* Drug: Oral Testosterone
* Drug: Acyline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acyline and oral testosterone<br> | Drug: Oral Testosterone<br>* Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills)<br>Drug: Acyline<br>* 300 ug/kg injection on Day 0<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Free T normal range 4.7-18 ng/dL | baseline & day 9 | 
| Free Testosterone Mean Concentration | Free T normal range 4.7-18 ng/dL | baseline & day 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Experimental, Acyline plus 27 oral testosterone pills, taken 3x/day