Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

NCT06140108 | Completed Phase 2 DMC

• 1 other identifier: 00002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

this is open labelled randomize control trial among women with PCOS. PCOS, an endocrine condition, affects 5%-15% of premenopausal women. PCOS is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. Metformin is now an option for PCOS. The clinical reactions to metformin are limited and varied. Novel SGLT2 inhibitors treat type 2 diabetes with weight loss, insulin resistance reduction, and cardiovascular benefits. There is little evidence on SGLT2 inhibitor effectiveness in PCOS patients.

Conditions

Polycystic Ovary Syndrome; Weight Gain; HbA1c

Outcome Measures

Primary Outcomes (1)

• Irregular menstruations assessment

  Assessment of Irregular menstruation measured by menstruations lasts 2 to 7 days after three months of treatment with either empagliflozin 10mg or metformin 1000mg daily.

  Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

Secondary Outcomes (6)

• Body weight

  Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

• Systolic Blood Pressure (SBP)

  Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

• Lipid profile measured through biochemical test

  Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

• Hb1c test

  Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

• fasting blood-glucose measured through biochemical test

  Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

Study Arms (2)

Empagliflozin 10mg

EXPERIMENTAL

Each participant will receive empagliflozin 10mg daily for 6 months

Drug: Empagliflozin 10 MG

Metformin 500mg

ACTIVE COMPARATOR

Each participant will receive metformin 1000mg daily for 6 months

Drug: MetFORMIN 500 Mg Oral Tablet

Interventions

Empagliflozin 10 MG DRUG

Each participant will receive empagliflozin 10mg daily for 6 months.

Also known as: EMPAA 10mg

Empagliflozin 10mg

MetFORMIN 500 Mg Oral Tablet DRUG

Each participant will receive metformin 1000mg daily for 6 months.

Also known as: Glucophage 500mg

Metformin 500mg

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: This study for women of reproductive age only
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All women participants belong to the reproductive age group, i.e., 18 to 45 years will be included in the study.
• All those women of BMI of greater than 25 kg/m2 will be included in this study
• Women with a diagnosis of PCOS by using two (hyperandrogenism and oligo-anovulation) out of three (oligo-anovulation, hyperandrogenism and polycystic ovaries) Rotterdam criteria 2 which confirm hyperandrogenism (acne, seborrhea, hair loss on the scalp, increased body or facial hair) on clinical judgement will be included in the study
• Those who documented and self-reported oligomenorrhea (cycle length greater than 35 days and nine or fewer periods per year) will be included. or
• PCO Women with or without comorbidity or Multimorbidity specifically, Hypothyroidism, Diabetes, Hypertension.

You may not qualify if:

• Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or androgen- secreting tumors will be streaked from participating.
• In addition to this, Pregnancy or intent to become pregnant, breastfeeding, documented use of oral hormonal contraceptives and hormone- releasing implants, clomiphene citrate or oestrogen modulators, gonadotropin-releasing hormone (GnRH) modulators and Minoxidil will be excluded.
• History or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study
• Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study.

Sponsors & Collaborators

• SINA Health Education and Welfare Trust: lead

Study Sites (1)

SINA Yousuf Sb Goth

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

• Sharif H, Arsalan S, Rehman N, Muzammil A, Hatif F, Wasti F, Rehman S, Mohsin N, Nasir R, Omair W. Comparative effects of empagliflozin and metformin on metabolic dysfunction in polycystic ovary syndrome, a double blinded randomized control feasibility trial. BMC Womens Health. 2025 Nov 19;25(1):565. doi: 10.1186/s12905-025-04091-6.

  PMID: 41257673 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Weight Gain

Interventions

empagliflozin; Metformin; Tablets

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; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Hina Sharif, PharmD,MSPH

  SINA Health Education & Welfare Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Manager

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: December 15, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)