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| Sponsors and Collaborators: |
University of Washington Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00729859 |
Purpose
The purpose of this research study is to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge will be used to help understand the effects of T and estrogen on cardiovascular (heart and blood vessel) disease. The knowledge will also be used to help in the development of a safe male hormonal contraceptive.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Acyline Drug: Acyline + Testosterone gel Drug: Acyline + testosterone gel + anastrozole |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men |
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Experimental
Acyline 300 µg/kg injections every two weeks (2 doses) + placebo (no active ingredients) gel daily for 28 days
|
Drug: Acyline
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + placebo Testosterone gel daily for 28 days
|
|
Group 2: Experimental
Acyline 300 µg/kg injections every two weeks (2 doses) + Testosterone gel 100 mg daily for 28 days + oral placebo pill daily for 28 days
|
Drug: Acyline + Testosterone gel
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days
|
|
Group 3: Experimental
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days
|
Drug: Acyline + testosterone gel + anastrozole
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days
|
We will be administering three drugs: Testim (testosterone gel) anastrozole and acyline. We want to see their effects on stem cells and hormone levels in the blood. Acyline suppress LH (luteinizing hormone) and FSH (follicle-stimulating hormone), which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore acyline blocks testosterone production. Some men may experience side effects such as hot flashes or irritability from the low levels of T caused by acyline. We are studying whether adding T to acyline will reduce or eliminate these side effects.
Since heart disease is a common problem in men we want to know about the effects of male hormonal contraception on the cardiovascular system. One way to evaluate these risks is to measure the number of progenitor cells and the types of cholesterol in the blood. Progenitor cells are cells that travel in the blood and go to areas of blood vessel injury to help repair the damage amd may help prevent heart attacks and stokes. Some studies suggest that T administration may increase the number of these cells in the blood but other studies have shown that estrogen may be responsible for this effect. In addition, T and estrogen may affect the amount and type of HDL cholesterol in the blood. This is the "good" cholesterol that is thought to protect people from heart attacks and strokes. Therefore, more studies to test the effects of T and estrogen on progenitor cells in the blood and to understand HDL cholesterol in men receiving testosterone are needed.
Acyline is an experimental drug. The FDA allows it use only in research with a small number of volunteers. So far, over on 125 men have received acyline. Anastrozole is a drug that blocks the production of estrogen from testosterone. Anastrozole had been given to men safely in the past. Anastrozole in not approved for use in men and is also an experimental drug. Testosterone gel will also be used in this study. It is FDA approved for ise in men with low testosterone levels.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Iris Nielsen | 206-221-5473 | malectr@u.washington.edu |
| Contact: Christin Snyder, MD | 206-616-3147 | cns6@u.washington.edu |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Sub-Investigator: Christin Snyder, MD | |
| Sub-Investigator: John Amory, MD, MPH | |
| Sub-Investigator: Mara Roth, MD | |
| Principal Investigator: | Stephanie Page, MD, PhD | University of Washington |
More Information
| Responsible Party: | University of Washington ( Stephanie T Page, MD, PhD ) |
| Study ID Numbers: | 33853-A |
| Study First Received: | August 5, 2008 |
| Last Updated: | February 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00729859 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anabolic Agents Testosterone Anastrozole Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Methyltestosterone Healthy Aromatase Inhibitors Hormones Androgens Testosterone 17 beta-cypionate |
|
Anastrozole Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Methyltestosterone |
Hormones Pharmacologic Actions Testosterone 17 beta-cypionate Testosterone Anabolic Agents Therapeutic Uses Aromatase Inhibitors Androgens |
