Clinical trial NCT00842751: Oral T7 Oral Testosterone in Man
Official title: Pharmacokinetics of a Novel Oral Testosterone Undecanoate Formulation With Concomitant Inhibition of 5alpha-Reductase by Finasteride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Males
Male Contraceptive
Keywords: 5α-reductase
androgen
dihydrotestosterone (DHT)
drug delivery
oestradiol
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-02-12
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Testosterone Concentration
timeFrame: 0,1,2,4,8,and 12-hour post dose
measure: Serum Dihydrotestosterone Concentration
timeFrame: 0,1,2,4,8,and 12-hour post dose
measure: Serum Estradiol Concentration
timeFrame: 0,1,2,4,8,and 12-hour post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: John K Amory, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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