Status:
COMPLETED
CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE2
Brief Summary
The original purpose of this research study was to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge would be used to help understand the effects of T a...
Detailed Description
We will be administering three drugs: testosterone gel (T), anastrozole, and acyline. We want to see their effects on stem cells and hormone levels in the blood. Acyline suppress luteinizing hormone(L...
Eligibility Criteria
Inclusion
- Males age 18-55 years
- 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
- Clinically significant screening assessments or other relevant disease, allergy or surgery, as revealed by history, physical examination and/or laboratory assessments, which may limit participation or prevent completion of the study
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00729859
Start Date
December 1 2008
End Date
May 1 2010
Last Update
October 12 2012
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