Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Overweight

Obesity

Polycystic Ovary Syndrome

Overnutrition

Nutrition Disorders

Body Weight

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Reproductive Control Agents

Anti-Obesity Agents

Antineoplastic Agents

Gastrointestinal Agents

Metformin

Liraglutide

Glucagon-Like Peptide-1 Receptor Agonists

Glucagon-Like Peptide 1

Contraceptive Agents

Exenatide

Contraceptives, Oral

Cyproterone Acetate

Cyproterone

Glucagon

Incretins

Hormones

Hormone Antagonists

Contraceptive Agents, Female

Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.

Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.

metformin oral with exenatide/liraglutide subcutaneous injection.

Metformin-GLP-1 Receptor Agonist

Metformin-Oral Contraceptive(OC)

Min long, MD

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.

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.

The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

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

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Concentration of LH was measured in mIU/ml.

Weight and height will be combined to report BMI in kg/m\^2.

Alanine transaminase was measured in IU/L.

Systolic blood pressure was measured in mmHg.

Changes in testosterone levels were measured

Xinqiao Hospital of Chongqing

Deputy Chief Physician, Associated professor

Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.

Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.

Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.

Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

China

Region of Enrollment

weight

Limitations of this trial include a relatively small sample size and single-center design.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS	NCT03151005	Polycystic Ovar... Overweight Obesity	Metformin-GLP-1... Metformin-Oral ...	18 Years - 50 Years	Xinqiao Hospital of Chongqing
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS	NCT03151005	Polycystic Ovar... Overweight Obesity	Metformin-GLP-1... Metformin-Oral ...	18 Years - 50 Years	Xinqiao Hospital of Chongqing

Spots Global Cancer Trial Database for oral contraceptives (ocs)