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

NCT ID: NCT06140108

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Empagliflozin 10mg

Each participant will receive empagliflozin 10mg daily for 6 months

Group Type: EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type: DRUG

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

Metformin 500mg

Each participant will receive metformin 1000mg daily for 6 months

Group Type: ACTIVE_COMPARATOR

MetFORMIN 500 Mg Oral Tablet

Intervention Type: DRUG

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

Interventions

Empagliflozin 10 MG

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

Intervention Type: DRUG

MetFORMIN 500 Mg Oral Tablet

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

Intervention Type: DRUG

Other Intervention Names

EMPAA 10mg; Glucophage 500mg

Eligibility Criteria

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

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

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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.

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• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SINA Health Education and Welfare Trust

OTHER

Sponsor Role: lead

Responsible Party

Hina Sharif

Assistant Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hina Sharif, PharmD,MSPH

Role: PRINCIPAL_INVESTIGATOR

SINA Health Education & Welfare Trust

Locations

SINA Yousuf Sb Goth

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

00002

Identifier Type: -

Identifier Source: org_study_id