SGLT2 Inhibitors in Patients With PCOS

NCT04700839 | Completed Phase 4

• 1 other identifier: SGLT2i PCOS
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome (PCOS);; Insulin resistance (IR); Sodium-glucose co-transporter-2 inhibitors (SGLT-2i); Canagliflozin

Outcome Measures

Primary Outcomes (1)

• HOMA-IR

  Homeostatic model assessment insulin resistance index

  3 months

Secondary Outcomes (32)

• WHR

  3 months

• WC

  3 months

• HC

  3 months

• Menstrual cycles

  3 months

• FBG

  3 months

Study Arms (2)

SGLT2 inhibitors group

EXPERIMENTAL

Intervention with SGLT2 inhibitors (100mg/d) for 3 months

Drug: SGLT2 inhibitors

Metformin group

ACTIVE COMPARATOR

Intervention with metformin (1500-2000mg/d) for 3 months

Drug: Metformin

Interventions

SGLT2 inhibitors DRUG

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.

Also known as: Canagliflozin tablets or Glucophage

SGLT2 inhibitors group

Metformin DRUG

Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients.

Metformin group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (2)

• 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.

  PMID: 30866088 RESULT

• 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. 2025 Dec 16. doi: 10.1002/phar.70092. Online ahead of print.

  PMID: 41401816 DERIVED

Related Links

• Efficacy of canagliflozin versus metformin in women with polycystic ovary syndrome: A randomized, open-label, noninferiority trial
• Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: a randomized controlled study

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Interventions

Sodium-Glucose Transporter 2 Inhibitors; Canagliflozin; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Biguanides; Guanidines; Amidines

Study Officials

• Shen Qu, Dr

  Shang hai Tenth People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: January 8, 2021
• Study Start: May 1, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 30, 2021
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)