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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Insulin Resistance, Type 2 Diabetes Mellitus, Obesity, Androgen Deficiency, Metabolic Disease

In brief

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

Key facts

Study ID

NCT01686828

Run by

University of Washington

People needed

53

Starts

2013-06-01

Expected to finish

2017-12-01

Last updated by the study team

2018-05-08

Who can join

Age: 25 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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