CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
metformin +3 moredrug
Likely dose
Metformin 1000 mg twice daily (after titration); leuprolide 3.75 mg injection every 4 weeksAI-extracted
Key inclusion· 4
  • ✓Postmenopausal women aged 50-79 years with absence of menses for ≥12 months; FSH >30 U/mL required for women 50-54 years
  • ✓At least one intact ovary
  • ✓Free testosterone and fasting insulin levels within required study parameters
  • ✓Capable of giving informed consent
Key exclusion· 10
  • ✕History of cancer requiring treatment within past 5 years
  • ✕Hospitalization for vascular disease in past 6 months
  • ✕Uncontrolled hypertension
  • ✕Congestive heart failure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00123110
NCT00123110Phase 2Completed
CompareCT.gov

Insulin Resistance and Testosterone in Non-Diabetic Postmenopausal Women

University of Pennsylvania·interventional·Posted Jul 22, 2005·Updated May 23, 2019

In Brief

A Phase 2 clinical trial evaluating metformin, leuprolide injection, and 2 other interventions for Insulin Resistance and Postmenopause. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsulin Resistance, Postmenopause
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA), The John A. Hartford Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pennsylvania Diabetes and Endocrinology Research Center (DERC), TAP Pharmaceutical Products Inc.

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2005
Enrollment StartJul 1, 2005
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 20.9 years ago

Interventions

metformindrug

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

leuprolide injectiondrug

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

placebo pilldrug

matching pill twice a day for 12 weeks

placebo injectiondrug

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