Overview

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