Oral T7 Oral Testosterone in Man

University of Washington11 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Males Male Contraceptive

Interventions

First Intervention (7 days)DRUG

Acyline 300mcg/kg subcutaneous (days 1, 15 \& 29) + testosterone undecanoate 200 mg, twice daily orally + finasteride placebo

First Washout (7 days)OTHER

Washout of 7 days between each of the 3 treatment arms

Second Intervention (7 days)DRUG

Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 0.5mg twice daily, orally

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

Maximum Testosterone Concentration

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.

Time frame: 0,1,2,4,8,and 12-hour post dose

Serum Dihydrotestosterone Concentration

Area under the curve of serum dihydrotestosterone

Time frame: 0,1,2,4,8,and 12-hour post dose

Serum Estradiol Concentration

Area under the curve of serum estradiol

Time frame: 0,1,2,4,8,and 12-hour post dose

Data from ClinicalTrials.gov

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