Oral T7 Oral Testosterone in Man

University of Washington

Status and phase: Completed; Phase 2

Conditions: Male Contraceptive; Healthy Males

Treatments: Other: First Washout (7 days); Drug: First Intervention (7 days); Drug: Third Intervention (7 days); Drug: Second Intervention (7 days); Other: Second wash-out period

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00842751

5U54HD042454 (U.S. NIH Grant/Contract)

1K23HD045386 (U.S. NIH Grant/Contract)

35724-W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 3 patient groups, including a placebo group

Testosterone Undecanoate + placebo finasteride

Placebo Comparator group

Description:

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)

Treatment:

Drug: First Intervention (7 days)

Other: First Washout (7 days)

Testosterone Undecanoate + Finasteride 0.5mg

Experimental group

Description:

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)

Treatment:

Other: Second wash-out period

Drug: Second Intervention (7 days)

Testosterone Undecanoate + Finasteride 1mg

Experimental group

Description:

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)

Treatment:

Drug: Third Intervention (7 days)