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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06140108
• Other study ID #: 00002
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 15, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2024
• Source: SINA Health Education and Welfare Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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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Related Conditions & MeSH terms

• HbA1c
• Polycystic Ovary Syndrome
• Syndrome
• Weight Gain

Intervention

Drug:
• Empagliflozin 10 MG
Each participant will receive empagliflozin 10mg daily for 3 months.
• MetFORMIN 500 Mg Oral Tablet
Each participant will receive metformin 1000mg daily for 3 months.

Locations

Country	Name	City	State
Pakistan	SINA Yousuf Sb Goth	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
SINA Health Education and Welfare Trust

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three months treatment with either empagliflozin 10mg or metformin 1000mg daily
Secondary	Body weight	assessment of change in Body weight in Kg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Three months treatment with either empagliflozin 10mg or metformin 1000mg daily
Secondary	Systolic Blood Pressure (SBP)	assessment of change in SBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Three months treatment with either empagliflozin 10mg or metformin 1000mg daily
Secondary	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	Three months treatment with either empagliflozin 10mg or metformin 1000mg daily
Secondary	Hb1c test	assessment of change in Hb1c level in percentage after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Three months treatment with either empagliflozin 10mg or metformin 1000mg daily
Secondary	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	Three months treatment with either empagliflozin 10mg or metformin 1000mg daily
Secondary	Diastolic Blood Pressure (DBP)	assessment of change in DBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily	Three months treatment with either empagliflozin 10mg or metformin 1000mg daily