MedTrace Logo

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

NCT01686828 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-05-08

Study results available
· View outcomes & findings →

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • William J Bremner, MD, PhD · University of Washington

  • Stephanie T Page, MD, PhD · University of Washington

  • Katya Rubinow, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-05-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01686828 on ClinicalTrials.gov