Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
NCT ID: NCT04969627
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2021-01-04
2022-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metformin (BMI<24)
Subjects: PCOS patients whoseBMI\<24 Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months
Metformin
Use Metformin for 3 months to treat PCOS
Metformin (BMI≥24)
Subjects: PCOS patients whoseBMI≥24 Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months
Metformin
Use Metformin for 3 months to treat PCOS
Combination (BMI<24)
Subjects: PCOS patients whoseBMI\<24 Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months
Metformin
Use Metformin for 3 months to treat PCOS
Exenatide
Use Exenatide for 3 months to treat PCOS
Combination (BMI≥24)
Subjects: PCOS patients whoseBMI≥24 Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months
Metformin
Use Metformin for 3 months to treat PCOS
Exenatide
Use Exenatide for 3 months to treat PCOS
Interventions
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Metformin
Use Metformin for 3 months to treat PCOS
Exenatide
Use Exenatide for 3 months to treat PCOS
Eligibility Criteria
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Inclusion Criteria
2. Overweight/obesity (BMI≥24 kg/m2)
3. No pregnant plan in recent 6 months
4. Written consent for participation in the study
Exclusion Criteria
2. Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
3. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
4. Serious systemic disease or malignant tumor
5. History of pancreatitis (chronic, acute or recurrent)
6. Body weight change ≥10% at 3 months before treatment
7. Used oral contraceptives or sex hormone drugs in the past 1 month
8. Used oral glucocorticoids in the past 1 month
9. Substance (alcohol or drug) abuse or dependence within 3 months
10. Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d)
11. Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR\<60ml/min/1.73m2)
12. Increase of transaminases up to \< 2.5 times of upper limit of normal value
13. Have a history of thromboembolic disease or thrombotic tendency
14. Subjects in pregnant or lactating or within 1 year after delivery
15. Subjects have an allergic history to the drugs used in the study
16. Subjects have participated in other clinical researches of medicine within 1 month prior to randomization
17. Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening
18 Years
40 Years
FEMALE
No
Sponsors
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Bing He
OTHER
Responsible Party
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Bing He
Professor
Locations
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Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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Other Identifiers
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2020PS624K
Identifier Type: -
Identifier Source: org_study_id
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