ORAL T-6: Oral Androgens in Man-6 (ORAL-T-6)

University of Washington

Status and phase: Completed; Phase 1

Conditions: Contraception; Hypogonadism

Treatments: Drug: Testosterone; Drug: Finasteride; Drug: Acyline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00663793

33738-B

K23HD045386 (U.S. NIH Grant/Contract)

U54HD42456-06 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Oral testosterone

Experimental group

Description:

(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.

Treatment:

Drug: Acyline

Drug: Testosterone

Finasteride plus Oral Testosterone

Experimental group

Description:

(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.

Treatment:

Drug: Acyline

Drug: Testosterone

Drug: Finasteride