DRUG
Metformin-GLP-1 Receptor Agonist
metformin oral with exenatide/liraglutide subcutaneous injection.
Status
Completed
Phase
Phase 4
Enrollment
70
Locations
1
Results
Posted
Publications
12
Study 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.
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.
Interventions
DRUG
metformin oral with exenatide/liraglutide subcutaneous injection.
DRUG
metformin with Diane 35 oral intake.
Timeline
First posted
May 12, 2017
Study start
Jul 1, 2017
Primary completion
Apr 1, 2021
Study completion
Apr 23, 2021
Results posted
Dec 4, 2023
Registry updated
Dec 4, 2023
Outcomes
Assessment of Reproductive Functions
Time frame · 12 weeks
Concentration of LH was measured in mIU/ml.
Basic Vital Signs
Time frame · 12 weeks
Weight and height will be combined to report BMI in kg/m\^2.
Assessment of Liver Function
Time frame · 12 weeks
Alanine transaminase was measured in IU/L.
Assessment of Blood Pressure
Time frame · 12 weeks
Systolic blood pressure was measured in mmHg.
Assessment of Reproductive Function
Time frame · 12 weeks
Changes in testosterone levels were measured
Eligibility
Inclusion Criteria: * Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism. * Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks. * Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese \[body mass index (BMI) \>=24 kg/m2 or waistline\>=85cm \]. * All subjects had normal thyroid-stimulating hormone and prolactin levels. Exclusion Criteria: * smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions. * age below 18 yr or over 50 yr. * postmenopausal. * uncontrolled hypertension (blood pressure \>=160/100 mm Hg). * preexisting OPs or GLP-1 agonists supplementation * alcohol intake greater than 20 g/d, or pregnancy. * signs of liver or renal failure or active liver disease (ALT \> 2.5× the upper limit of normal values). * PLT\<60\*10\^9/L,Hb\<100g/L, smoking, alcohol use. * The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
The Second Affiliated Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Publications
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