T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Treatments: Acyline; Androgens; Aromatase Inhibitors; Insulin; Insulin, Globin Zinc; Letrozole; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Prostate-specific antigen (PSA) ≤ 3 ng/mL

• Age 25-55 years

• Ability to understand the study, study procedures and provide informed consent

• Serum total T > 300 ng/dL

• Normal reproductive history and exam

• International Prostate Symptom Score (IPSS) < 11

Exclusion Criteria:

• A history of prostate cancer including suspicious digital rectal exam (DRE) or history of highgrade prostatic intraepithelial neoplasia (PIN) on prostate biopsy

• Invasive therapy for benign prostatic hyperplasia (BPH) in the past

• History of acute urinary retention in the previous 3 months

• Current or recent past use of androgenic or anti-androgenic drugs, steroids or drugs which interfere with steroid metabolism (within the last 3 months)

• Current use of statins or glucocorticoids

• Severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes mellitus) or skin disease

• A history of or current breast cancer

• Known, untreated obstructive sleep apnea

• Hematocrit > 50 or < 34

• Hypersensitivity to any of the drugs used in the study

• History of a bleeding disorder or anticoagulation

• Participation in any other drug study within past 90 days

• History of drug or alcohol abuse within the last 12 months

• Weight > 280 lbs. or BMI ≥ 33

• Desire for fertility in the next 6 months or current pregnant partner

• Sperm concentration <14 million/ml

• Significant, uncontrolled hypertension (BP >160/100 mmHg); subjects with well-controlled BP on medical therapy will be eligible to participate