Oral Androgens in Man-4: (Short Title: Oral T-4)

Study Overview
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Brief Summary
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The protocol was designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In addition, we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in the normal range throughout the day, with the same dose (800 mg once daily) administered once daily. This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval

Detailed Description
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This study will be carried out in a double-blinded fashion, so neither the subject nor the investigator will be aware of treatment assignment during the study. This protocol is designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In addition, we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in the normal range throughout the day, with the same dose (800 mg once daily) administered once daily. This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval. Secondary endpoints in this study include the ability of oral testosterone enanthate plus dutasteride to maintain short-term androgen-mediated endpoints such as mood and sexual function over the 4-week treatment period as well as weekly measures of safety, including blood counts, PSA and liver and kidney function.

Official Title
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Oral Androgens in Man-4: Gonadotropin Suppression Medicated by Oral Testosterone Enanthate in Oil Plus Dutasteride (Short Title: Oral T-4)

Conditions
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Contraception

Intervention / Treatment
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* Drug: Testosterone Enanthate
* Drug: Testosterone Enanthate
* Drug: Dutasteride
* Other: placebo sesame oil
* Drug: Dutasteride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males between 18 to 55 years of age In good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal serum chemistry, hematology, and baseline hormone levels) Subject must agree not to participate in another research drug study for the duration of the study Subject must agree to not donate blood during the study Subject must be willing to comply with the study protocol and procedures Exclusion Criteria: Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values) A known history of alcohol or drug abuse A history of testicular disease or severe testicular trauma, A history of bleeding disorders or current use of anti-coagulants A history of sleep apnea and/or major psychiatric disorders A body-mass index greater than 35, A history of or current use of testosterone Infertility

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oral Testosterone enanthate in sesame oil, 400 mg po (orally), BID (twice daily) + dutasteride 0.5 mg orally, qd (once daily) for 28 days + dutasteride load 24.5 mg po once | Drug: Testosterone Enanthate<br>* Oral Testosterone 400 mg orally for 28 days<br>* Other names: Delatestryl;Drug: Dutasteride<br>* dutasteride 0.5 mg orally, once daily for 28 days<br>* Other names: Avodart;Drug: Dutasteride<br>* 24.5 mg po once (Day 0)<br>* Other names: Avodart;|
| Active Comparator: 2<br>Oral Testosterone sesame oil, 800 mg po (orally), qd (in am daily) + placebo sesame oil (in pm daily) + dutasteride 0.5 mg orally, qd (once daily) for 28 days + dutasteride load 24.5 mg po once | Drug: Testosterone Enanthate<br>* Oral Testosterone 800 mg orally for 28 days<br>* Other names: Delatestryl;Drug: Dutasteride<br>* dutasteride 0.5 mg orally, once daily for 28 days<br>* Other names: Avodart;Other: placebo sesame oil<br>* placebo sesame oil<br>Drug: Dutasteride<br>* 24.5 mg po once (Day 0)<br>* Other names: Avodart;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dutasteride can suppress the secretion of LH and FSH after four weeks of administration. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability of oral testosterone enanthate plus dutasteride to maintain short-term androgen-medicated endpoints such as mood and sexual function over the 4-week treatment period |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Contraception for Men, Contraceptive agent