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

Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Weight Gain; HbA1c
• Intervention / Treatment: Drug: Empagliflozin 10 MG; Drug: MetFORMIN 500 Mg Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • SINA Yousuf Sb Goth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. All women participants belong to the reproductive age group, i.e., 18 to 45 years will be included in the study.
2. All those women of BMI of greater than 25 kg/m2 will be included in this study
3. 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
4. Those who documented and self-reported oligomenorrhea (cycle length greater than 35 days and nine or fewer periods per year) will be included. or
5. Those who report amenorrhea (absence of menses for a period of 3 months) will be inclusion criteria of the study.

6- PCO Women with or without comorbidity or Multimorbidity specifically, Hypothyroidism, Diabetes, Hypertension.

-

Exclusion Criteria:

1. Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or androgen- secreting tumors will be streaked from participating.
2. 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.
3. History or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study

4. Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study.

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empagliflozin 10mg; Each participant will receive empagliflozin 10mg daily for 6 months	Drug: Empagliflozin 10 MG; Each participant will receive empagliflozin 10mg daily for 6 months.; Other Names: EMPAA 10mg
Active Comparator: Metformin 500mg; Each participant will receive metformin 1000mg daily for 6 months	Drug: MetFORMIN 500 Mg Oral Tablet; Each participant will receive metformin 1000mg daily for 6 months.; Other Names: Glucophage 500mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	assessment of change in Body weight in Kg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
Systolic Blood Pressure (SBP)	assessment of change in SBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
Lipid profile measured through biochemical test	assessment of change in Blood Pressure in mg/dL after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
Hb1c test	assessment of change in Hb1c level in percentage after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
fasting blood-glucose measured through biochemical test	assessment of fasting blood-glucose in mmol/L after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
Diastolic Blood Pressure (DBP)	assessment of change in DBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

Collaborators and Investigators

• Sponsor: SINA Health Education and Welfare Trust
• Investigators: Principal Investigator: Hina Sharif, PharmD,MSPH, SINA Health Education & Welfare Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Body Weight; Body Weight Changes; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Syndrome; Polycystic Ovary Syndrome; Weight Gain; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin; Metformin
• Other Study ID Numbers: 00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes