CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Male

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 and estrogen on cardiovascular (heart and blood vessel) disease, and to help in the development of a safe male hormonal contraceptive.

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Acyline; Anastrozole; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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