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Insulin Resistance and Testosterone in Women

NCT00123110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-05-23

Study results available
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Summary

The purpose of this research study is to determine if a relationship between insulin resistance (IR) and testosterone (T) exists in women who have already gone through menopause.

Conditions

Interventions

DRUG

metformin

Initiated on 500 mg daily and titrated up to 1000 mg twice a day during the first four weeks, remaining at that dose until 12 weeks

DRUG

leuprolide injection

3.75 mg injection every 4 weeks (e.g. at baseline, 4, and 8 weeks)

DRUG

placebo pill

matching pill twice a day for 12 weeks

DRUG

placebo injection

matching injection every 4 weeks (e.g. baseline, 4, and 8 weeks)

Sponsors & Collaborators

  • University of Pennsylvania

    lead OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • The John A. Hartford Foundation

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Pennsylvania Diabetes and Endocrinology Research Center (DERC)

    collaborator OTHER

  • TAP Pharmaceutical Products Inc.

    collaborator INDUSTRY

Principal Investigators

  • Anne R. Cappola, MD, ScM · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

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 NCT00123110 on ClinicalTrials.gov