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Polycystic Ovary SyndromePhase 4PCOSNCT04700839

SGLT2 Inhibitors in Patients With PCOS

A Phase 4 study testing SGLT2 inhibitors and Metformin in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
1 May 2020to 30 Apr 2021
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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Fmale aged 18- 45;
  • Meet Rotterdam criteria;
  • Insulin Rsistance

Who cannot join

  • Women who are pregnant or have a pregnancy plan within six months; ·Congenital adrenocortical hyperplasia;
  • Hyperprolactinemia;
  • Hyperthyroidism or hypothyroidism;
  • Abnormal liver function (≥ 3 times of the upper limit of normal range);
  • Abnormal renal function (GFR<60ml/min/1.73m2);
  • Adrenal or ovarian tumors secreting androgens;
  • Used contraceptives, metformin, GLP-1RA, SGLT2I, pioglitazone and contraceptives in the last 3 month.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Tenth People' Hospital

    Shanghai, Shanghai Municipality, 200072

Other trials in China

About this study

Official title: The Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome: A Randomized, Open Label Trial

Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Metformin has been clarified as an option in patients with PCOS. However, the clinical responses to metformin are limited and different. Sodium glucose co-transporter 2 (SGLT2) inhibitors are novel drugs for the treatment of type 2 diabetes, with weight loss, reducing insulin resistance and cardiovascular benefits. Limited data is available on the efficacy of SGLT2 inhibitors in patients with PCOS.

Read the detailed description

This clinical study aims to determine the safety and efficacy of canagliflozin vs metformin in Polycystic Ovary Syndrome (PCOS) patients with insulin resistance (IR). Methods: A single center, prospective, randomized open-label study (ratio 1:1), non-inferiority trial was conducted in the department of endocrinology, Shanghai Tenth People's Hospital between July 2019 and April 2021. PCOS women aged 18-45 years with IR were enrolled and randomly assigned to either canagliflozin 100 mg (n = 33) or metformin 1500-2000 mg (n = 35) daily for 12 weeks. The primary outcome was changes in HOMA-IR after 12 weeks treatment. The secondary outcomes included changes in anthropometric, menstrual frequency, sex hormone and metabolic parameters.

Being tested
SGLT2 inhibitors, Metformin
Keywords
Polycystic ovary syndrome (PCOS);, Insulin resistance (IR), Sodium-glucose co-transporter-2 inhibitors (SGLT-2i), Canagliflozin
Medical subject headings
Polycystic Ovary Syndrome, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGLT2 inhibitorsDrug

    Also called Canagliflozin tablets or Glucophage

    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 groups in NCT04700839
Study groupRoleWhat they receive
SGLT2 inhibitors groupExperimentalIntervention with SGLT2 inhibitors (100mg/d) for 3 months
Receives: Drug: SGLT2 inhibitors
Metformin groupActive comparatorIntervention with metformin (1500-2000mg/d) for 3 months
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HOMA-IR

    Homeostatic model assessment insulin resistance index

    Measured: 3 months

Secondary outcomes (32)

  1. WHR

    Waist/hip Ratio

    Measured: 3 months

  2. WC

    Waist Circumference (cm）

    Measured: 3 months

  3. HC

    Hip Circumference（cm）

    Measured: 3 months

  4. Menstrual cycles

    annual number of menstrual cycles

    Measured: 3 months

  5. FBG

    fasting blood-glucose in mmol/L

    Measured: 3 months

  6. PBG

    postprandial blood-glucose in mmol/L

    Measured: 3 months

  7. FINS

    fasting serum insulin in mU/L

    Measured: 3 months

  8. PINS

    Postprandial insulin in mU/L

    Measured: 3 months

  9. ALT

    alanine aminotransferase in U/L

    Measured: 3 months

  10. AST

    Aspartate aminotransferase in U/L

    Measured: 3 months

  11. UA

    Uric acid in umol/L

    Measured: 3 months

  12. CR

    Creatinine in umol/L

    Measured: 3 months

  13. LDL-c

    low-density lipoprotein cholesterol in mmol/L

    Measured: 3 months

  14. HDL-c

    high-density lipoprotein cholesterol in mmol/L

    Measured: 3 months

  15. TC

    Total Cholesterol in mmol/L

    Measured: 3 months

  16. TG

    Triglyceride in mmol/L

    Measured: 3 months

  17. TT

    total testosterone in nmol/L

    Measured: 3 months

  18. LH

    Luteinizing hormone in IU/L

    Measured: 3 months

  19. FSH

    follicle-stimulating hormone in IU/L）

    Measured: 3 months

  20. E2

    Estradiol in pmol/L、PRL(Prolactin in uIU/ml)

    Measured: 3 months

  21. PRL

    Prolactin in uIU/ml

    Measured: 3 months

  22. Metabonomics

    the change of Metabonomics after the treatment

    Measured: 3 months

  23. Ferriman-Gallwey score

    Ferriman-Gallwey score、acne, male pattern baldness

    Measured: 3 months

  24. acne score

    male pattern baldness

    Measured: 3 months

  25. male pattern baldness

    male pattern baldness

    Measured: 3 months

  26. HOMA- ISI

    Homeostatic model assessment insulin sensitivity index

    Measured: 3 months

  27. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Adverse events and Safety data in two treatment groups.

    Measured: 3 months

  28. BMI

    body mass index in kg/m^2

    Measured: 3 months

  29. SHBG

    sex hormone binding globulin in nmol/L

    Measured: 3 months

  30. FT

    Free testosterone in pg/ml

    Measured: 3 months

  31. DHEAS

    Dehydroepiandrosterone Sulfate in ug/dl

    Measured: 3 months

  32. AD

    Androstenedione in ng/ml

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2021
  2. Study start1 May 2020
  3. Primary completion28 Apr 2021
  4. Study completion30 Apr 2021

Resources

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
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04700839
Sponsor's protocol ID
SGLT2i PCOS
Acronym
PCOS
Status last verified
Sep 2022
First submitted
5 Aug 2020
Last updated
10 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Javed Z, Papageorgiou M, Deshmukh H, Rigby AS, Qamar U, Abbas J, Khan AY, Kilpatrick ES, Atkin SL, Sathyapalan T. Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: A randomized controlled study. Clin Endocrinol (Oxf). 2019 Jun;90(6):805-813. doi: 10.1111/cen.13968. Epub 2019 Apr 2.

    PubMed 30866088

  • Yan Q, Cai M, Wang N, Wu W, Zhang H, Zhu Y, Luo J, Zhang M, Li J. Circulating Profiles of the Bile Acid Metabolomics in Patients With Polycystic Ovary Syndrome Treated With Metformin or Canagliflozin. Pharmacotherapy. 2026 Feb;46(2):e70092. doi: 10.1002/phar.70092. Epub 2025 Dec 16.

    PubMed 41401816

Questions about this trial

What is this clinical trial studying?

A Phase 4 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 10 Sep 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?

HOMA-IR (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04700839, which also lists 2 linked publications.

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 10 Sep 2022.

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