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| Sponsor: | University of Washington |
|---|---|
| Collaborators: |
National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00842751 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Males |
Drug: Acyline Drug: Testosterone Undecanoate Drug: Finasteride 0.5 mg Drug: Finasteride 1 mg |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Oral Androgens in Man-7: Pharmacokinetics of a Novel Oral Testosterone Undecanoate Formulation With Concomitant Inhibition of 5alpha-Reductase by Finasteride |
| Estimated Enrollment: | 12 |
| Study Start Date: | July 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Period 1
Testosterone Undecanoate 200 mg, BID orally
|
Drug: Acyline
300 ug/kg SQ injections, Days 0, 15 and 29
Other Name: Acyline GnRH antagonist
Drug: Testosterone Undecanoate
200 mg BID orally, Days 1-7, 15-21 and 29-35
Other Name: TU
|
|
Experimental: Period 2
Testosterone Undecanoate (TU), BID and Finasteride 0.5 mg, BID orally
|
Drug: Acyline
300 ug/kg SQ injections, Days 0, 15 and 29
Other Name: Acyline GnRH antagonist
Drug: Testosterone Undecanoate
200 mg BID orally, Days 1-7, 15-21 and 29-35
Other Name: TU
Drug: Finasteride 0.5 mg
0.5 mg BID orally, Days 1-7, 15-21 and 29-35
Other Name: Propecia
|
|
Experimental: Period 3
Testosterone Undecanoate 200 mg BID orally and Finasteride 1 mg, BID orally
|
Drug: Acyline
300 ug/kg SQ injections, Days 0, 15 and 29
Other Name: Acyline GnRH antagonist
Drug: Testosterone Undecanoate
200 mg BID orally, Days 1-7, 15-21 and 29-35
Other Name: TU
Drug: Finasteride 1 mg
1 mg BID orally, Days 1-7, 15-21 and 29-35
Other Name: Propecia
|
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| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | John K Amory, MD, MPH | University of Washington |
More Information
| Responsible Party: | John K Amory, MD, MPH, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00842751 History of Changes |
| Other Study ID Numbers: | 35724-W, 1K23HD045386, 5U54HD042454 |
| Study First Received: | February 10, 2009 |
| Last Updated: | April 21, 2010 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Oral Testosterone Acyline Finasteride |
|
Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Androgens Methyltestosterone Finasteride Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
