Exenatide and Metformin Therapy in Overweight Women With PCOS

NCT00344851 · Completed

Last updated 2026-05-28

This clinical trial tests whether the medications exenatide and metformin can help improve menstrual regularity in overweight women with polycystic ovary syndrome (PCOS) over a 24-week period.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 60 people

Who can join Ages 18–40 · female only Healthy volunteers accepted.

Timeline Started 2006-06 · est. completion 2007-06

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT00344851 ↗

Description as written by the study sponsor.

Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS.

Treatments tested

metformin, exenatide or combined (metformin & exenatide ) Drug

Main thing measured	- Menstrual Cyclicity ( # menses/ 24 weeks)
Sponsor	Metabolic Center of Louisiana Research Foundation
Conditions studied	Polycystic Ovary Syndrome
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00344851 ↗