Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.

NCTNCT04969627Other id2020PS624K

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 60 participants (actual)
Sponsor: Bing He · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 4 Jan 2021
Primary completion: 4 Jan 2022
Completion: 29 Mar 2022
First posted: 21 Jul 2021
Last update posted: 14 Apr 2022
Conditions: Polycystic Ovary Syndrome

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 4
Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
NCT04969627
4 Jan 2021 to 29 Mar 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To study the effects of GLP-1 analogues combined with metformin and metformin on gonadal and metabolic profiles in PCOS patients with BMI ≥ 24 in China. 60 cases of overweight PCOS patients were collected from Shengjing hospital. The intervention period was 3 months after intervention with met or met + GLP-1. To evaluate the improvement of met or met + GLP-1 in the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation, hairiness and acne in PCOS patients with different BMI.

Interventions

MetforminDrug
ExenatideDrug

Arms4

Active comparator
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
Experimental
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
Experimental
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
Experimental
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in body weight
Time frame · 12 weeks
Registry description
Change in body weight

Secondary outcomes(17)

Change in body mass index (BMI)
Time frame · 12 weeks
Registry description
Change in body mass index (BMI)
Change in waist circumference(WC)
Time frame · 12 weeks
Registry description
Change in waist circumference(WC)
Change in Ferriman-Gallwey score
Time frame · 12 weeks
Registry description
Change in Ferriman-Gallwey score，the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome.
Change in Acne severity score
Time frame · 12 weeks
Registry description
Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome.
Changes in frequency of menstrual cycle
Time frame · 12 weeks
Registry description
Changes in frequency of menstrual cycle
Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
Time frame · 12 weeks
Registry description
glucose obtained at 0,30,60 and 120 minutes during the OGTT.
Changes in Luteinizing Hormone (LH)
Time frame · 12 weeks
Registry description
Changes in Luteinizing Hormone (LH)
Changes in follicle stimulating hormone (FSH)
Time frame · 12 weeks
Registry description
Changes in follicle stimulating hormone (FSH)
Changes in LH/FSH
Time frame · 12 weeks
Registry description
Changes in LH/FSH
Changes in prolactin (PRL)
Time frame · 12 weeks
Registry description
Changes in prolactin (PRL)
Changes in progesterone (Prog)
Time frame · 12 weeks
Registry description
Changes in progesterone (Prog)
Changes in total testosterone (TT)
Time frame · 12 weeks
Registry description
Changes in total testosterone (TT)
Changes in free testosterone (FT)
Time frame · 12 weeks
Registry description
Changes in free testosterone (FT)
Changes in free androgen index (FAI)
Time frame · 12 weeks
Registry description
Changes in free androgen index (FAI)
Changes in sex hormone binding globulin (SHBG)
Time frame · 12 weeks
Registry description
Changes in sex hormone binding globulin (SHBG)
Changes in dehydroepiandrosterone sulfate (DHEAS)
Time frame · 12 weeks
Registry description
Changes in dehydroepiandrosterone sulfate (DHEAS)
Changes in anti-müllerian hormone (AMH)
Time frame · 12 weeks
Registry description
Changes in anti-müllerian hormone (AMH)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam 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: 1. type 1 or type 2 diabetes mellitus 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

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