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

Last updated: May 8, 2025
Sponsor: SINA Health Education and Welfare Trust
Overall Status: Completed

Phase

2/3

Condition

Obesity

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

MetFORMIN 500 Mg Oral Tablet

Empagliflozin 10 MG

Clinical Study ID

NCT06140108
00002
  • Ages 15-49
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. All women participants belong to the reproductive age group, i.e., 18 to 45 yearswill 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) Rotterdamcriteria 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 35days 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 beinclusion criteria of the study.

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

Exclusion

  • Exclusion Criteria:
  1. Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing'sdisease, 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 fromthe study.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: MetFORMIN 500 Mg Oral Tablet
Phase: 2/3
Study Start date:
December 15, 2023
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • SINA Yousuf Sb Goth

    Karachi, Sindh 74800
    Pakistan

    Site Not Available

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