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CompletedNCT06140108Updated May 14, 2025

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

A Phase 2/3 interventional study of Empagliflozin 10 MG and MetFORMIN 500 Mg Oral Tablet in Polycystic Ovary Syndrome, Weight Gain and HbA1c, sponsored by SINA Health Education and Welfare Trust. Completed at 1 site in Pakistan. Open to female participants aged 15 Years to 49 Years. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by SINA Health Education and Welfare Trust · Phase 2/3, Interventional, and Basic science

Phase
Phase 2/3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
15 Years to 49 Years
Sex
Female
01

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.

02

Conditions studied

  • Polycystic Ovary Syndrome
  • Weight Gain
  • HbA1c
03

Who can participate

Ages eligible
15 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

-

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.

    -

04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Empagliflozin 10mg

    Each participant will receive empagliflozin 10mg daily for 6 months

    Drug: Empagliflozin 10 MG

  • Active comparator
    Metformin 500mg

    Each participant will receive metformin 1000mg daily for 6 months

    Drug: MetFORMIN 500 Mg Oral Tablet

Interventions

  • DrugEmpagliflozin 10 MG

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

    Also known as: EMPAA 10mg

  • DrugMetFORMIN 500 Mg Oral Tablet

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

    Also known as: Glucophage 500mg

05

What researchers measure

Primary outcomes

  1. Irregular menstruations assessment

    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.

    Time frame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

Secondary outcomes

  1. Body weight

    assessment of change in Body weight in Kg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Time frame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  2. Systolic Blood Pressure (SBP)

    assessment of change in SBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Time frame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  3. Lipid profile measured through biochemical test

    assessment of change in Blood Pressure in mg/dL after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Time frame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  4. Hb1c test

    assessment of change in Hb1c level in percentage after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Time frame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  5. fasting blood-glucose measured through biochemical test

    assessment of fasting blood-glucose in mmol/L after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Time frame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  6. Diastolic Blood Pressure (DBP)

    assessment of change in DBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Time frame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

06

Study locations

1 site
  • SINA Yousuf Sb Goth
    Karachi, Sindh 74800, Pakistan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06140108
Lead sponsor
SINA Health Education and Welfare Trust
Responsible party
Hina Sharif (Assistant Manager, SINA Health Education and Welfare Trust) — Principal investigator
First posted
Nov 18, 2023
Start date
Dec 15, 2023
Primary completion
May 30, 2024
Completion
Jun 30, 2024
Last update
May 14, 2025

Study contacts

Hina Sharif, PharmD,MSPH
principal investigator · SINA Health Education & Welfare Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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