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

SINA Health Education and Welfare Trust

Status and phase: Completed; Phase 3; Phase 2

Conditions: Weight Gain; HbA1c; Polycystic Ovary Syndrome

Treatments: Drug: Empagliflozin 10 MG; Drug: MetFORMIN 500 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06140108

00002

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Empagliflozin 10mg

Experimental group

Description:

Each participant will receive empagliflozin 10mg daily for 6 months

Treatment:

Drug: Empagliflozin 10 MG

Metformin 500mg

Active Comparator group

Description:

Each participant will receive metformin 1000mg daily for 6 months

Treatment:

Drug: MetFORMIN 500 Mg Oral Tablet