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Completed

NCT Number: NCT06140108

Empagliflozin vs 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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Body Weight Changes Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders HbA1c Neoplasms Ovarian Cysts Ovarian Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Weight Gain

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

SINA Yousuf Sb Goth

Karachi, Sindh, 74800, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.

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Exclusion criteria

  • 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.

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Treatment and study plan

Empagliflozin 10 MG

Drug

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

Other names: EMPAA 10mg

MetFORMIN 500 Mg Oral Tablet

Drug

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

Other names: Glucophage 500mg

Primary outcomes

  1. Irregular menstruations assessment

    Time frame: 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 outcomes

  1. Body weight

    Time frame: 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

  2. Systolic Blood Pressure (SBP)

    Time frame: 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

  3. Lipid profile measured through biochemical test

    Time frame: 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

  4. Hb1c test

    Time frame: 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

  5. fasting blood-glucose measured through biochemical test

    Time frame: 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

  6. Diastolic Blood Pressure (DBP)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

SINA Health Education and Welfare Trust

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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