Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-28 @ 3:47 AM
Study NCT ID:
NCT03151005
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS
Sponsor:
Xinqiao Hospital of Chongqing
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Groups:
Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.
Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.
Time Point:
Initial treatment;
Post-treatment (4w);
Post-treatment (8w);
Post-treatment (12w);
Assess reproductive functions and cardiovascular risk factors.
Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.
Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.
Time Point:
Initial treatment;
Post-treatment (4w);
Post-treatment (8w);
Post-treatment (12w);
Assess reproductive functions and cardiovascular risk factors.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: