Status:
COMPLETED
Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity
Lead Sponsor:
SINA Health Education and Welfare Trust
Conditions:
Polycystic Ovary Syndrome
Weight Gain
Eligibility:
FEMALE
15-49 years
Phase:
PHASE2
PHASE3
Brief 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 diff...
Eligibility Criteria
Inclusion
- All women participants belong to the reproductive age group, i.e., 18 to 45 years will be included in the study.
- All those women of BMI of greater than 25 kg/m2 will be included in this study
- 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
- Those who documented and self-reported oligomenorrhea (cycle length greater than 35 days and nine or fewer periods per year) will be included. or
- 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.
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Exclusion
- 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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Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06140108
Start Date
December 15 2023
End Date
June 30 2024
Last Update
May 14 2025
Active Locations (1)
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1
SINA Yousuf Sb Goth
Karachi, Sindh, Pakistan, 74800