Oral T7 Oral Testosterone in Man

Phase 2

Completed

• Conditions: Healthy Males; Male Contraceptive
• Interventions: Drug: First Intervention (7 days); Drug: Second Intervention (7 days); Drug: Third Intervention (7 days); Other: First Washout (7 days); Other: Second wash-out period

• Registration Number: NCT00842751
• Lead Sponsor: University of Washington

Brief Summary

The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

Detailed Description

We will be using three drugs: The first, acyline, temporarily turns off the body's production of testosterone for about two weeks. Subjects will receive acyline as shots three times over a six-week drug administration period. During the time when the body's production of testosterone is turned off, we will give testosterone either by itself or with a medication called finasteride by mouth twice daily for one week to see how much is absorbed and present in the bloodstream after administration. Subjects will go through three one-week study drug exposure periods. During two of the three one-week study drug administration periods subjects will also take a second medication, finasteride, by mouth twice daily. On the last day of each one-week drug administration period, subjects will be admitted to the University of Washington General Clinical Research Center overnight for monitoring of your blood testosterone levels. There will be 3 overnight visits for this study. This study will allow us to determine the absorption of testosterone taken by mouth, and the relative impact of two different doses of oral finasteride on testosterone absorption.

Study Timeline

• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-12
• Study Start: 2009-07
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Results First Submitted: 2011-03-21
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Results First Posted: 2014-01-13
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

• Males between 18 and 50 years of age
• In good health based on normal screening evaluation (consisting of a medical history, physical exam normal serum chemistry, hematology, and baseline hormone levels.
• Must agree to not participate in another research drug study
• Must agree to not donate blood
• Must be willing to comply with the study protocol and procedures

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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
• Participation in a long-term male contraceptive study within the past month
• History of bleeding disorders or current use of anti-coagulants
• History of sleep apnea
• History of major psychiatric disorder
• Body mass index > 37
• Infertility
• Hematocrit > 55 or < 30
• PSA >4

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Testosterone Undecanoate + placebo finasteride	First Intervention (7 days)	Acyline 300mcg/kg subcutaneous on days 1, 15 and 29 + Testosterone Undecanoate (TU)200mg twice daily, orally for 7 days + placebo finasteride twice daily, orally for 7 days during one of the three intervention periods (First Intervention, Second Intervention or Third Intervention)
Testosterone Undecanoate + placebo finasteride	First Washout (7 days)	Acyline 300mcg/kg subcutaneous on days 1, 15 and 29 + Testosterone Undecanoate (TU)200mg twice daily, orally for 7 days + placebo finasteride twice daily, orally for 7 days during one of the three intervention periods (First Intervention, Second Intervention or Third Intervention)
Testosterone Undecanoate + Finasteride 0.5mg	Second Intervention (7 days)	Acyline 300mcg/kg subcutaneous on days 1, 15 \& 29 + testosterone undecanoate 200mg, twice daily orally for 7 days + finasteride 0.5mg twice daily, orally for 7 days during one of the three intervention periods (First Intervention, Second Intervention or Third Intervention)
Testosterone Undecanoate + Finasteride 0.5mg	Second wash-out period	Acyline 300mcg/kg subcutaneous on days 1, 15 \& 29 + testosterone undecanoate 200mg, twice daily orally for 7 days + finasteride 0.5mg twice daily, orally for 7 days during one of the three intervention periods (First Intervention, Second Intervention or Third Intervention)
Testosterone Undecanoate + Finasteride 1mg	Third Intervention (7 days)	Acyline 300mcg/kg subcutaneous on days 1, 15 \& 29 + testosterone undecanoate 200mg, twice daily orally for 7 days + finasteride 1mg twice daily, orally for 7 days during one of the three intervention periods ((First Intervention, Second Intervention or Third Intervention)

Primary Outcome Measures

Name	Time	Method
Serum Estradiol Concentration	0,1,2,4,8,and 12-hour post dose	Area under the curve of serum estradiol
Serum Dihydrotestosterone Concentration	0,1,2,4,8,and 12-hour post dose	Area under the curve of serum dihydrotestosterone
Maximum Testosterone Concentration	0,1,2,4,8,and 12-hour post dose	Area under the curve of serum testosterone Pharmacokinetic measures time-weighted mean concentration calculated as area under the concentration curve (AUC) divided by time from initiation of dosing for the morning dose and corrected for differences in baseline hormone concentration.

Trial Locations

Locations (1)

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