Polycystic Ovary SyndromeNCT05966792
SGLT2 Inhibitors in Treating Patients With PCOS
A study testing SGLT2 inhibitors and metformin in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Chronic inflammation is the core of Polycystic ovary syndrome (PCOS), and obesity and overweight further exacerbate the level of inflammation in the peripheral circulation and ovarian tissue in PCOS patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- SGLT2 inhibitors and metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2023to 30 Jun 2025
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female aged 18-45
- Meet Rotterdam criteria
- BMI≥20kg/m2
Who cannot join
- Treatment with any additional medications that might impede the trial, including GLP-1 RAs, metformin, pioglitazone, contraceptives, or traditional Chinese medicine within the past 3 months
- Pregnancy or lactation
- Mental illness
- Malignant tumors
- Chronic kidney disease or severe liver dysfunction
- Inflammatory bowel disease
- Involvement in other research programs within the past 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People'S Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: The Clinical Efficacy and Mechanism of SGLT2 Inhibitors Treating Polycystic Ovary Syndrome by Modulating the Nod-like Receptor Protein 3 Inflammasome
Chronic inflammation is the core of Polycystic ovary syndrome (PCOS), and obesity and overweight further exacerbate the level of inflammation in the peripheral circulation and ovarian tissue in PCOS patients. Metformin is a classic endocrine drug for the treatment of PCOS, but its clinical response rate is only about 40%. Our previous published study (Diabetes Obes Metab, 2022) observed that the new hypoglycemic drug SGLT-2 inhibitor can significantly improve the clinical symptoms of patients with insulin resistance PCOS, and the clinical efficacy is not inferior to metformin, but its specific mechanism of action is not clear. Recent studies have shown that SGLT-2 significantly attenuates the activation of the Nod-like receptor protein 3 (NLRP3) inflammasomes and the secretion of IL-1β in patients with type 2 diabetes mellitus at high risk of cardiovascular disease. Based on the above research background, this project will combine clinical research and mechanism exploration to solve the following two problems:
- whether SGLT2 inhibitor can further improve the clinical efficacy of PCOS patients compared to metformin;
- mechanistic studies further clarify whether SGLT2 inhibitors improve inflammatory symptoms by modulating NLRP3 inflammosomes in the treatment of polycystic ovary syndrome;
Read the detailed description
This clinical study is a prospective, single-center, randomized (1:1) controlled clinical study. The enrollment population is overweight or obese PCOS patients. After signing the informed consent form, patients who meet the inclusion/exclusion criteria will be randomly assigned to the experimental and control groups for treatment in a 1:1 ratio, for a total of 80 patients enrolled.
Subjects randomized to the trial group will receive SGLT-2 inhibitors for 24 weeks.
Participants randomised to control will receive metformin for 24 weeks.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- SGLT2 inhibitors, metformin
- 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.
SGLT2 inhibitorsDrug
Sodium-glucose cotransporters inhibitors (SGLT2i) are novel hypoglycemic drugs with unique hypoglycemic mechanisms, which are completely independent of islet β-cell function or insulin sensitivity. Previous studies have shown that SGLT2i may improve IR by inhibiting glucotoxicity, reducing body weight, reducing inflammation, improving islet β-cell function, and reducing oxidative stress.
metforminDrug
Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients.
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 inhibitors | Experimental | Intervention with henggliflozin (10mg qd) for 6 months Receives: Drug: SGLT2 inhibitors |
| metformin | Placebo comparator | Intervention with metformin (500mg bid) for 6 months Receives: Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual cycles
annual number of menstrual cycles
Measured: 6 months
Secondary outcomes (11)
HOMA-IR
Homeostatic model assessment insulin resistance index
Measured: 6 months
NLRP3
serum Nod-like receptor protein 3
Measured: 6 months
IL-1β
serum Interleukin-1 beta
Measured: 6 months
IL-18
serum Interleukin-18
Measured: 6 months
LH
luteinizing hormone
Measured: 6 months
FSH
follicle-stimulating hormone
Measured: 6 months
PRL
prolactin
Measured: 6 months
E2
estradiol
Measured: 6 months
P
progesterone
Measured: 6 months
TT
total testosterone
Measured: 6 months
AMH
antimullerian hormone antimullerian hormone antimullerian hormone antimullerian hormone
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start10 Nov 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
- Investigators
- Manna Zhang, PhD, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966792
- Sponsor's protocol ID
- SGLT2i in PCOS
- Status last verified
- Jun 2025
- First submitted
- 21 Jul 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy and Mechanism of SGLT2 Inhibitors Treating Polycystic Ovary Syndrome by Modulating the Nod-like Receptor Protein 3 Inflammasome
- ClinicalTrials.gov ID
- NCT05966792
- Acronym / sponsor ID
- SGLT2i in PCOS
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 1 Aug 2023 (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.
Chronic inflammation is the core of Polycystic ovary syndrome (PCOS), and obesity and overweight further exacerbate the level of inflammation in the peripheral circulation and ovarian tissue in PCOS patients. Metformin is a classic endocrine drug for the treatment of PCOS, but its clinical response rate is only about 40%. Our previous published study (Diabetes Obes Metab, 2022) observed that the new hypoglycemic drug SGLT-2 inhibitor can significantly improve the clinical symptoms of patients with insulin resistance PCOS, and the clinical efficacy is not inferior to metformin, but its specific mechanism of action is not clear. Recent studies have shown that SGLT-2 significantly attenuates the activation of the Nod-like receptor protein 3 (NLRP3) inflammasomes and the secretion of IL-1β in patients with type 2 diabetes mellitus at high risk of cardiovascular disease. Based on the above research background, this project will combine clinical research and mechanism exploration to solve the following two problems:
- whether SGLT2 inhibitor can further improve the clinical efficacy of PCOS patients compared to metformin;
- mechanistic studies further clarify whether SGLT2 inhibitors improve inflammatory symptoms by modulating NLRP3 inflammosomes in the treatment of polycystic ovary syndrome;
Detailed description
This clinical study is a prospective, single-center, randomized (1:1) controlled clinical study. The enrollment population is overweight or obese PCOS patients. After signing the informed consent form, patients who meet the inclusion/exclusion criteria will be randomly assigned to the experimental and control groups for treatment in a 1:1 ratio, for a total of 80 patients enrolled.
Subjects randomized to the trial group will receive SGLT-2 inhibitors for 24 weeks.
Participants randomised to control will receive metformin for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2 inhibitors | Experimental | Drug: SGLT2 inhibitorsIntervention with henggliflozin (10mg qd) for 6 months |
| metformin | Placebo comparator | Drug: metforminIntervention with metformin (500mg bid) for 6 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female aged 18-45
- Meet Rotterdam criteria
- BMI≥20kg/m2
Key exclusion criteria (7 listed)
- Treatment with any additional medications that might impede the trial, including GLP-1 RAs, metformin, pioglitazone, contraceptives, or traditional Chinese medicine within the past 3 months
- Pregnancy or lactation
- Mental illness
- Malignant tumors
- Chronic kidney disease or severe liver dysfunction
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 |
|---|---|---|
| SGLT2 inhibitorsSodium-glucose cotransporters inhibitors (SGLT2i) are novel hypoglycemic drugs with unique hypoglycemic mechanisms, which are completely independent of islet β-cell function or insulin sensitivity. Previous studies have shown that SGLT2i may improve IR by inhibiting glucotoxicity, reducing body weight, reducing inflammation, improving islet β-cell function, and reducing oxidative stress. | Drug | SGLT2 inhibitors |
| metforminMetformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients. | Drug | metformin |
Primary outcome
Menstrual cycles
Time frame: 6 months
annual number of menstrual cycles
11 secondary outcomes
HOMA-IR
Time frame: 6 months
NLRP3
Time frame: 6 months
IL-1β
Time frame: 6 months
IL-18
Time frame: 6 months
LH
Time frame: 6 months
FSH
Time frame: 6 months
PRL
Time frame: 6 months
E2
Time frame: 6 months
P
Time frame: 6 months
TT
Time frame: 6 months
AMH
Time frame: 6 months
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Manna Zhang, PhD principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGLT2 inhibitors and metformin in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital 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 3 inclusion and 7 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 13 Apr 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Menstrual cycles (time frame: 6 months). 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 13 Apr 2026.