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

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome; HbA1c; Weight Gain
• Interventions: Drug: Empagliflozin 10 MG; Drug: MetFORMIN 500 Mg Oral Tablet

• Registration Number: NCT06140108
• Lead Sponsor: SINA Health Education and Welfare Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-18
• Study Start: 2023-12-15
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin 10mg	Empagliflozin 10 MG	Each participant will receive empagliflozin 10mg daily for 6 months
Metformin 500mg	MetFORMIN 500 Mg Oral Tablet	Each participant will receive metformin 1000mg daily for 6 months

Primary Outcome Measures

Name	Time	Method
Irregular menstruations assessment	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily	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.

Secondary Outcome Measures

Name	Time	Method
Body weight	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily	assessment of change in Body weight in Kg after three 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	assessment of change in SBP in mm/Hg after three 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	assessment of change in Blood Pressure in mg/dL after three months treatment with either empagliflozin 10mg or metformin 1000mg daily
Hb1c test	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily	assessment of change in Hb1c level in percentage after three 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	assessment of fasting blood-glucose in mmol/L after three months treatment with either empagliflozin 10mg or metformin 1000mg daily
Diastolic Blood Pressure (DBP)	Six months treatment with either empagliflozin 10mg or metformin 1000mg daily	assessment of change in DBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

Trial Locations

Locations (1)

SINA Yousuf Sb Goth; 🇵🇰 Karachi, Sindh, Pakistan