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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Katya Rubinow, University of Washington
ClinicalTrials.gov Identifier:
NCT01686828
First received: September 12, 2012
Last updated: November 3, 2014
Last verified: November 2014

September 12, 2012
November 3, 2014
June 2013
June 2017   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Glucose disposal assessed by frequently sampled oral glucose tolerance test (OGTT)
Insulin sensitivity index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Glucose disposal assessed by frequently sampled intravenous glucose tolerance test (FG-IGT)
Complete list of historical versions of study NCT01686828 on ClinicalTrials.gov Archive Site
  • Changes in body composition [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Changes in adipose tissue gene expression [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin
Androgen-mediated Pathways in the Regulation of Insulin Sensitivity in Men

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

The investigators will examine the effects of testosterone on insulin sensitivity and body composition in men. This study may lend greater insight into the increased risk of diabetes evident in men with low circulating levels of testosterone. Three drugs will be used in this study: acyline, given by injection; testosterone (T) gel that is applied to the skin; and letrozole, which is an oral drug that blocks the conversion of androgens (male hormones) to estrogens (female hormones). Acyline inhibits the production of luteinizing hormone (LH) and follicle stimulating hormone (FSH). When acyline stops the production of these hormones, it blocks the signal from the brain that stimulates the testicles to make testosterone. Adding testosterone to acyline will restore physiologic levels of testosterone in some study participants. One group of men will receive T gel with letrozole, an aromatase inhibitor; these men will have normal levels of testosterone but low levels of estrogen in the blood. This design will enable determination of the respective metabolic effects of testosterone and estrogen.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Insulin Resistance
  • Type 2 Diabetes Mellitus
  • Obesity
  • Androgen Deficiency
  • Metabolic Disease
  • Drug: Acyline
    300 mcg/mL administered subcutaneously (at Day 0, Week 2)
  • Drug: Testosterone 1.62% gel
    Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks
    Other Name: Androgel
  • Drug: Letrozole
    Letrozole oral aromatase inhibitor 5mg daily for 4 weeks
    Other Name: Femara
  • Drug: Placebo gel (for Testosterone 1.62% gel)
    placebo gel manufactured to mimic Testosterone 1.62% gel
  • Drug: Placebo pill (for Letrozole)
    Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d
  • Experimental: Acyline & placebo gel & placebo pill
    Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks
    Interventions:
    • Drug: Acyline
    • Drug: Placebo gel (for Testosterone 1.62% gel)
    • Drug: Placebo pill (for Letrozole)
  • Experimental: Acyline & Testosterone Gel 1.25g/d & placebo pill
    Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks
    Interventions:
    • Drug: Acyline
    • Drug: Testosterone 1.62% gel
    • Drug: Placebo pill (for Letrozole)
  • Experimental: Acyline & Testosterone Gel 5g/d & placebo pill
    Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks
    Interventions:
    • Drug: Acyline
    • Drug: Testosterone 1.62% gel
    • Drug: Placebo pill (for Letrozole)
  • Experimental: Acyline & Testosterone gel & Letrozole
    Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks
    Interventions:
    • Drug: Acyline
    • Drug: Testosterone 1.62% gel
    • Drug: Letrozole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2017
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 DRE or history of highgrade PIN on prostate biopsy
  • Invasive therapy for 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
Male
25 Years to 55 Years
Yes
Contact: Katya Rubinow, MD 206-616-1818 rubinow@uw.edu
Contact: Genecelle Delossantos 206 779-9496 gen7@uw.edu
United States
 
NCT01686828
43007-B
Yes
Katya Rubinow, University of Washington
University of Washington
Not Provided
Study Chair: William J Bremner, MD, PhD University of Washington
Study Director: Stephanie T Page, MD, PhD University of Washington
Principal Investigator: Katya Rubinow, MD University of Washington
University of Washington
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP