CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men
Condition: Healthy
Intervention: Acyline; Acyline + Testosterone gel; Acyline + testosterone gel + anastrozole
Intervention description: 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 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 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
Intervention MeSH terms: Methyltestosterone; Anastrozole; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Acyline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 31.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HDL; Insulin sensitivity; testosterone; estradiol; cholesterol

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.
    

Eligibility 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