CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Metformin-GLP-1 Receptor Agonist +1 moredrug
Likely dose
Not stated in 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/NCT03151005
NCT03151005Phase 4Completed
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Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients

Xinqiao Hospital of Chongqing·interventional·Posted May 12, 2017·Updated Dec 4, 2023

In Brief

A Phase 4 clinical trial evaluating Metformin-GLP-1 Receptor Agonist and Metformin-Oral Contraceptive(OC) for Polycystic Ovary Syndrome (PCOS) and 2 related conditions. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome (PCOS), Overweight, Obesity
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 12, 2017
Enrollment StartJul 1, 2017
Primary CompletionApr 1, 2021
Study CompletionApr 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.1 years ago

Interventions

Metformin-GLP-1 Receptor Agonistdrug

metformin oral with exenatide/liraglutide subcutaneous injection.

Metformin-Oral Contraceptive(OC)drug

metformin with Diane 35 oral intake.