ORAL T-6: Oral Androgens in Man-6

Phase 1

Completed

• Conditions: Contraception; Hypogonadism
• Interventions: Drug: Acyline; Drug: Testosterone; Drug: Finasteride

• Registration Number: NCT00663793
• Lead Sponsor: University of Washington

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-22
• Study Start: 2008-10
• Primary Completion: 2009-05
• Study Completion: 2009-06
• Results First Submitted: 2010-06-25
• Status Verified: 2010-12
• Results First Submitted QC: 2010-12-27
• Last Update Submitted: 2010-12-27
• Results First Posted: 2011-01-24
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral testosterone	Testosterone	(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.
Finasteride plus Oral Testosterone	Finasteride	(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.
Finasteride plus Oral Testosterone	Testosterone	(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.
Oral testosterone	Acyline	(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.
Finasteride plus Oral Testosterone	Acyline	(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.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve-Serum T	14 days

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve-serum DHT	14-days
Area Under the Curve-E2	14 Days

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States