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

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT00399165

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Arms

5.9

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Testosterone Enanthate Drug: Testosterone Enanthate Drug: Dutasteride Other: placebo sesame oil Drug: Dutasteride	Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 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 Oral Testosterone 400 mg orally for 28 days Other Names: Delatestryl Drug: Dutasteride dutasteride 0.5 mg orally, once daily for 28 days Other Names: Avodart Drug: Dutasteride 24.5 mg po once (Day 0) Other Names: Avodart
Active Comparator: 2 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 Oral Testosterone 800 mg orally for 28 days Other Names: Delatestryl Drug: Dutasteride dutasteride 0.5 mg orally, once daily for 28 days Other Names: Avodart Other: placebo sesame oil placebo sesame oil Drug: Dutasteride 24.5 mg po once (Day 0) Other Names: Avodart

Arm

Intervention/Treatment

Active Comparator: 1

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

Oral Testosterone 400 mg orally for 28 days

Other Names:

Delatestryl

Drug: Dutasteride

dutasteride 0.5 mg orally, once daily for 28 days

Other Names:

Avodart

Drug: Dutasteride

24.5 mg po once (Day 0)

Other Names:

Avodart

Active Comparator: 2

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

Oral Testosterone 800 mg orally for 28 days

Other Names:

Delatestryl

Drug: Dutasteride

dutasteride 0.5 mg orally, once daily for 28 days

Other Names:

Avodart

Other: placebo sesame oil

placebo sesame oil

Drug: Dutasteride

24.5 mg po once (Day 0)

Other Names:

Avodart

Outcome Measures

Primary Outcome Measures

Dutasteride can suppress the secretion of LH and FSH after four weeks of administration. [4 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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