Clinical trial NCT06140108: Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity
Official title: Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Polycystic Ovary Syndrome
Weight Gain
HbA1c
Lead sponsor: SINA Health Education and Welfare Trust
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.


Eligibility criteria: 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.

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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.

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Primary outcomes:
measure: Irregular menstruations assessment
timeFrame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
Secondary outcomes:
measure: Body weight
timeFrame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
measure: Systolic Blood Pressure (SBP)
timeFrame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
measure: Lipid profile measured through biochemical test
timeFrame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
measure: Hb1c test
timeFrame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
measure: fasting blood-glucose measured through biochemical test
timeFrame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
measure: Diastolic Blood Pressure (DBP)
timeFrame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: SINA Yousuf Sb Goth
state: Sindh
Study officials:
affiliation: SINA Health Education & Welfare Trust
name: Hina Sharif, PharmD,MSPH
role: PRINCIPAL_INVESTIGATOR
References: