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

Sponsor
SINA Health Education and Welfare Trust
Study ID
NCT06140108
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • HbA1c
  • Polycystic Ovary Syndrome
  • Weight Gain

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Each participant will receive empagliflozin 10mg daily for 6 months.
  • MetFORMIN 500 Mg Oral Tablet — DRUG
    Each participant will receive metformin 1000mg daily for 6 months.

Study Details

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.

Key Dates

Start date
Dec 15, 2023
Status verified
May 2025
Primary completion
May 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Empagliflozin 10mg
    Each participant will receive empagliflozin 10mg daily for 6 months
  • Active Comparator: Metformin 500mg
    Each participant will receive metformin 1000mg daily for 6 months

Primary Outcome Measure

Irregular menstruations assessment [ Time Frame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily ]

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