CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men
NCT ID: NCT00729859
Last Updated: 2012-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2008-12-31
2010-05-31
Brief Summary
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The effect of androgens on the number of circulating endothelial progenitor (CEP) cells would best be observed in group 1 (placebo). Upon observation of group 1 under original protocol, changes in CEP cells were not significant but there were changes in markers of inflammation, lipids, and HDL protein composition. A modification to the protocol and title were made to reflect this for groups 2 and 3: Hormonal regulation of HDL-C in Men.
Detailed Description
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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 its use only in research with a small number of volunteers. So far, over 125 men have received acyline. Anastrozole is a drug that blocks the production of estrogen from testosterone. Anastrozole has been given to men safely in the past. Anastrozole is 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 use in men with low testosterone levels.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1
Acyline 300 µg/kg injections every two weeks (2 doses) + placebo (no active ingredients) gel daily for 28 days + oral placebo pill daily for 28 days
Acyline
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + placebo Testosterone gel daily for 28 days + placebo oral anastrozole pill daily for 28 days
Group 2
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
Acyline + Testosterone gel
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + placebo oral pill 1 mg daily for 28 days
Group 3
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + oral anastrozole pill 1 mg daily for 28 days
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 + oral anastrozole pill 1 mg daily for 28 days
Interventions
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Acyline
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + placebo Testosterone gel daily for 28 days + placebo oral anastrozole pill daily for 28 days
Acyline + Testosterone gel
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + placebo oral pill 1 mg daily for 28 days
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 + oral anastrozole pill 1 mg daily for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal serum total testosterone (300 ng/dl-1000 ng/dl)
* Normal LH and FSH levels
* Taking no regular medications
* Normal baseline serum hematology, chemistry and liver function tests
* Agrees not to donate blood during the study
* Agrees to use a form of contraception during the study
* Subject must be able to comply with all study procedures
Exclusion Criteria
* History of prostate cancer, breast cancer, or benign prostatic hypertrophy
* Prostate-specific antigen (PSA) \> 3.0
* History of regular, chronic testosterone or anabolic steroid use in the past year
* Chronic medical illness, prostate disease, or cardiovascular disease
* History of a bleeding disorder or need for anticoagulation
* Skin condition that might interfere with or be exacerbated by T gel use
* Sitting systolic blood pressure \> 180mm Hg or \<90 mm Hg or sitting diastolic blood pressure \>110 mm Hg or \< 60 mm Hg.
* History of clinically significant, untreated sleep apnea
* Participation in another drug-related research study within the past 2 months
* Participating in a regular physical relationship with a pregnant woman
* History of hypersensitivity to any of the study medications (T gel, anastrozole, acyline)
* History of medical or surgical therapy for benign prostatic hypertrophy
* Hematocrit \> 55%
* History of drug or alcohol abuse within last 6 months
* Abnormal digital rectal exam at screening
18 Years
55 Years
MALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Washington
OTHER
Responsible Party
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Stephanie T. Page
Associate Professor
Principal Investigators
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Stephanie Page, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Countries
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References
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Mostaghel EA, Page ST, Lin DW, Fazli L, Coleman IM, True LD, Knudsen B, Hess DL, Nelson CC, Matsumoto AM, Bremner WJ, Gleave ME, Nelson PS. Intraprostatic androgens and androgen-regulated gene expression persist after testosterone suppression: therapeutic implications for castration-resistant prostate cancer. Cancer Res. 2007 May 15;67(10):5033-41. doi: 10.1158/0008-5472.CAN-06-3332.
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Rubinow KB, Snyder CN, Amory JK, Hoofnagle AN, Page ST. Acute testosterone deprivation reduces insulin sensitivity in men. Clin Endocrinol (Oxf). 2012 Feb;76(2):281-8. doi: 10.1111/j.1365-2265.2011.04189.x.
Rubinow KB, Tang C, Hoofnagle AN, Snyder CN, Amory JK, Heinecke JW, Page ST. Acute sex steroid withdrawal increases cholesterol efflux capacity and HDL-associated clusterin in men. Steroids. 2012 Apr;77(5):454-60. doi: 10.1016/j.steroids.2012.01.002. Epub 2012 Jan 15.
Other Identifiers
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33853-A
Identifier Type: -
Identifier Source: org_study_id