CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Metformindrug
Likely dose
Metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00670800
NCT00670800N/ACompleted
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Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome

University of Michigan·interventional·Posted May 2, 2008·Updated May 21, 2014

In Brief

A clinical study evaluating Metformin for Polycystic Ovary Syndrome. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effects of insulin resistance on brain function in women with Polycystic Ovary Syndrome (PCOS). PCOS affected women will be evaluated prior to and following 4-month treatment with Metformin. Additionally, brain function in women with PCOS will be compared to the brain activity in normal control subjects with regular menstrual cycles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2, 2008
Enrollment StartJan 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.2 years ago

Interventions

Metformindrug

Following the baseline studies, PCOS affected women will be initiated on metformin at a dose of 500 mg orally after breakfast and the dose will be increased the following week to 500 mg twice daily (BID), adding a dose after lunch. On the third week, the dose will be increased to 500 mg three times daily (TID), adding a 500 mg tablet after supper. All subjects will be monitored for possible side effects such as nausea, vomiting, diarrhea, anorexia, and abdominal discomfort. These side effects tend to be mild, dose-related and improve with continued use of metformin. Hypoglycemia is rare and tends to occur in the setting of alcohol abuse or prolonged starvation. Malabsorption of vitamin B12 and folate occurs with long-term treatment, although it usually does not lead to anemia.