Polycystic Ovary SyndromePhase 4NCT04969627
Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
A Phase 4 study testing Metformin and Exenatide in people with Polycystic Ovary Syndrome, run by Bing He at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin and Exenatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2021to 29 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
- Overweight/obesity (BMI≥24 kg/m2)
- No pregnant plan in recent 6 months
- Written consent for participation in the study
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Exenatide
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Use Metformin for 3 months to treat PCOS
ExenatideDrug
Use Exenatide for 3 months to treat PCOS
| Study group | Role | What they receive |
|---|---|---|
| Metformin (BMI<24) | Active comparator | 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 Receives: Drug: Metformin |
| Metformin (BMI≥24) | Experimental | 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 Receives: Drug: Metformin |
| Combination (BMI<24) | Experimental | 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 Receives: Drug: Metformin; Drug: Exenatide |
| Combination (BMI≥24) | Experimental | 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 Receives: Drug: Metformin; Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Change in body weight
Measured: 12 weeks
Secondary outcomes (17)
Change in body mass index (BMI)
Change in body mass index (BMI)
Measured: 12 weeks
Change in waist circumference(WC)
Change in waist circumference(WC)
Measured: 12 weeks
Change in Ferriman-Gallwey score
Change in Ferriman-Gallwey score，the range of Ferriman-Gallwey score is 0-9, higher scores mean a worse outcome.
Measured: 12 weeks
Change in Acne severity score
Change in Acne severity score,the range of acne severity score is 0-9, higher scores mean a worse outcome.
Measured: 12 weeks
Changes in frequency of menstrual cycle
Changes in frequency of menstrual cycle
Measured: 12 weeks
Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
glucose obtained at 0,30,60 and 120 minutes during the OGTT.
Measured: 12 weeks
Changes in Luteinizing Hormone (LH)
Changes in Luteinizing Hormone (LH)
Measured: 12 weeks
Changes in follicle stimulating hormone (FSH)
Changes in follicle stimulating hormone (FSH)
Measured: 12 weeks
Changes in LH/FSH
Changes in LH/FSH
Measured: 12 weeks
Changes in prolactin (PRL)
Changes in prolactin (PRL)
Measured: 12 weeks
Changes in progesterone (Prog)
Changes in progesterone (Prog)
Measured: 12 weeks
Changes in total testosterone (TT)
Changes in total testosterone (TT)
Measured: 12 weeks
Changes in free testosterone (FT)
Changes in free testosterone (FT)
Measured: 12 weeks
Changes in free androgen index (FAI)
Changes in free androgen index (FAI)
Measured: 12 weeks
Changes in sex hormone binding globulin (SHBG)
Changes in sex hormone binding globulin (SHBG)
Measured: 12 weeks
Changes in dehydroepiandrosterone sulfate (DHEAS)
Changes in dehydroepiandrosterone sulfate (DHEAS)
Measured: 12 weeks
Changes in anti-müllerian hormone (AMH)
Changes in anti-müllerian hormone (AMH)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start4 Jan 2021
- Primary completion4 Jan 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bing He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bing He, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969627
- Sponsor's protocol ID
- 2020PS624K
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
- ClinicalTrials.gov ID
- NCT04969627
- Acronym / sponsor ID
- 2020PS624K
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bing HeUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metformin (BMI<24) | Active comparator | Drug: MetforminSubjects: 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 (BMI≥24) | Experimental | Drug: MetforminSubjects: 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 |
| Combination (BMI<24) | Experimental | Drug: Metformin, Drug: ExenatideSubjects: 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 |
| Combination (BMI≥24) | Experimental | Drug: Metformin, Drug: ExenatideSubjects: 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
- Overweight/obesity (BMI≥24 kg/m2)
- No pregnant plan in recent 6 months
- Written consent for participation in the study
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminUse Metformin for 3 months to treat PCOS | Drug | Combination (BMI<24), Combination (BMI≥24), Metformin (BMI<24), Metformin (BMI≥24) |
| ExenatideUse Exenatide for 3 months to treat PCOS | Drug | Combination (BMI<24), Combination (BMI≥24) |
Primary outcome
Change in body weight
Time frame: 12 weeks
Change in body weight
17 secondary outcomes
Change in body mass index (BMI)
Time frame: 12 weeks
Change in waist circumference(WC)
Time frame: 12 weeks
Change in Ferriman-Gallwey score
Time frame: 12 weeks
Change in Acne severity score
Time frame: 12 weeks
Changes in frequency of menstrual cycle
Time frame: 12 weeks
Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
Time frame: 12 weeks
Changes in Luteinizing Hormone (LH)
Time frame: 12 weeks
Changes in follicle stimulating hormone (FSH)
Time frame: 12 weeks
Changes in LH/FSH
Time frame: 12 weeks
Changes in prolactin (PRL)
Time frame: 12 weeks
Changes in progesterone (Prog)
Time frame: 12 weeks
Changes in total testosterone (TT)
Time frame: 12 weeks
Changes in free testosterone (FT)
Time frame: 12 weeks
Changes in free androgen index (FAI)
Time frame: 12 weeks
Changes in sex hormone binding globulin (SHBG)
Time frame: 12 weeks
Changes in dehydroepiandrosterone sulfate (DHEAS)
Time frame: 12 weeks
Changes in anti-müllerian hormone (AMH)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Exenatide in people with Polycystic Ovary Syndrome, run by Bing He at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.