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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin 10mg | Experimental | Each participant will receive empagliflozin 10mg daily for 6 months |
|
| Metformin 500mg | Active Comparator | Each participant will receive metformin 1000mg daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG | Drug | Each participant will receive empagliflozin 10mg daily for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months treatment with either empagliflozin 10mg or metformin 1000mg daily |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | assessment of change in Body weight in Kg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily | Six months treatment with either empagliflozin 10mg or metformin 1000mg daily |
| Systolic Blood Pressure (SBP) |
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Inclusion Criteria:
6- PCO Women with or without comorbidity or Multimorbidity specifically, Hypothyroidism, Diabetes, Hypertension.
-
Exclusion Criteria:
Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or androgen- secreting tumors will be streaked from participating.
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.
History or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study
Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study.
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This study for women of reproductive age only
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| Name | Affiliation | Role |
|---|---|---|
| Hina Sharif, PharmD,MSPH | SINA Health Education & Welfare Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SINA Yousuf Sb Goth | Karachi | Sindh | 74800 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41257673 | Derived | Sharif H, Arsalan S, Rehman N, Muzammil A, Hatif F, Wasti F, Rehman S, Mohsin N, Nasir R, Omair W. Comparative effects of empagliflozin and metformin on metabolic dysfunction in polycystic ovary syndrome, a double blinded randomized control feasibility trial. BMC Womens Health. 2025 Nov 19;25(1):565. doi: 10.1186/s12905-025-04091-6. |
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| MetFORMIN 500 Mg Oral Tablet | Drug | Each participant will receive metformin 1000mg daily for 6 months. |
|
|
assessment of change in SBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily
| 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 | 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 | 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 | 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 | Six months treatment with either empagliflozin 10mg or metformin 1000mg daily |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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