Status:
UNKNOWN
Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic...
Eligibility Criteria
Inclusion
- Females 18 years to 40 years of age
- Diagnosed as PCOS by the 2003 Rotterdam criteria.
- Overweight/obesity (BMI≥25 kg/m2)
- No pregnant plan in recent 6 months
- Written consent for participation in the study
Exclusion
- type 1 or type 2 diabetes mellitus
- Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
- Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Serious systemic disease or malignant tumor
- History of pancreatitis (chronic, acute or recurrent)
- Body weight change ≥10% at 3 months before treatment
- Used oral contraceptives or sex hormone drugs in the past 1 month
- Used oral glucocorticoids in the past 1 month
- Substance (alcohol or drug) abuse or dependence within 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d)
- Subjects have a severe systemic disease, such as cardiovascular system
- Renal impairment, eGFR\<60ml/min/1.73m2
- Increase of transaminases up to \< 2.5 times of upper limit of normal value
- Have a history of thromboembolic disease or thrombotic tendency
- Subjects in pregnant or lactating or within 1 year after delivery.
- Subjects have an allergic history to the drugs used in the study
- Subjects have participated in other clinical researches of medicine within 1 month prior to randomization.
- Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening.
Key Trial Info
Start Date :
July 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04029272
Start Date
July 20 2019
End Date
December 31 2020
Last Update
July 23 2019
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 1000730