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
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 70 is close to the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →SINA Health Education and Welfare Trust is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
6- PCO Women with or without comorbidity or Multimorbidity specifically, Hypothyroidism, Diabetes, Hypertension.
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Exclusion Criteria:
Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant will receive empagliflozin 10mg daily for 6 months
Drug: Empagliflozin 10 MG
Each participant will receive metformin 1000mg daily for 6 months
Drug: MetFORMIN 500 Mg Oral Tablet
Each participant will receive empagliflozin 10mg daily for 6 months.
Also known as: EMPAA 10mg
Each participant will receive metformin 1000mg daily for 6 months.
Also known as: Glucophage 500mg
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
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
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2023 to primary completion in May 2024, 5 months.
Of 13 phase 2/3 interventional studies under Polycystic Ovary Syndrome, half reached primary completion within 12 months of starting (the median); a quarter within 8 and three quarters within 26. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Empagliflozin
SINA Health Education and Welfare Trust