ORAL T-6: Oral Androgens in Man-6

Study Overview
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Brief Summary
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We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

Detailed Description
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This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six different oral formulations of T in both rapid and slow release compared to the immediate release preparation studied previously by our group.

Official Title
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Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism

Conditions
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Contraception, Hypogonadism

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males between 18 to 50 years of age in good general health based on normal screening evaluation must agree not to participate in another research drug study during participation must agree to not donate blood during the study must be willing to comply with the study protocol and procedures must agree to use an acceptable form of contraception agrees to not take medications other than the study drugs for the duration of the study Exclusion Criteria: Subject in poor health, determined by medical history physical and lab results a known history or current use of alcohol, drug or steroid abuse and/or use of more than 3 alcohol beverages per day Participation in a long-term contraceptive study within the past two months History of bleeding disorders or current use of anti-coagulants History of sleep apnea and/or major psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral testosterone<br>(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once. | Drug: Acyline<br>* 300 mcg/kg<br>Drug: Testosterone<br>* 24 hours after acyline administration on Day 2 immediate release Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once.<br>* Other names: Oral Testosterone;|
| Experimental: Finasteride plus Oral Testosterone<br>(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once. | Drug: Acyline<br>* 300 mcg/kg<br>Drug: Testosterone<br>* 24 hours after acyline administration on Day 2 immediate release Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once.<br>* Other names: Oral Testosterone;Drug: Finasteride<br>* 1 mg PO once daily [day -2 to day 12) 14 days total<br>* Other names: Hyplafin, Penester, Finpros, Tectum, Prezepa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve-Serum T |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve-serum DHT |  | 14-days | 
| Area Under the Curve-E2 |  | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Contraception, Hypogonadism, Testosterone