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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

May 31, 2015

Study Completion Date

December 31, 2017

Conditions
Insulin ResistanceType 2 Diabetes MellitusObesityAndrogen DeficiencyMetabolic Disease
Interventions
DRUG

Acyline

300 mcg/mL administered subcutaneously (at Day 0, Week 2)

DRUG

Testosterone 1.62% gel

Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks

DRUG

Letrozole

Letrozole oral aromatase inhibitor 5mg daily for 4 weeks

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

Trial Locations (1)

98195

University of Washington, Seattle

All Listed Sponsors
lead

University of Washington

OTHER

NCT01686828 - T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin | Biotech Hunter | Biotech Hunter