Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome.

• Sponsor: SINA Health Education and Welfare Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06140108
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.5
• Patients Per Site Per Month: 12.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Weight Gain; HbA1c	Drug: Empagliflozin 10 MG; Drug: MetFORMIN 500 Mg Oral Tablet	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome.
• Anticipated Study Start Date: Dec 15, 2023
• Anticipated Primary Completion Date: May 30, 2024
• Anticipated Study Completion Date: May 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Empagliflozin 10mg Each participant will receive empagliflozin 10mg daily for 3 months	Drug: Empagliflozin 10 MG; Each participant will receive empagliflozin 10mg daily for 3 months.; Other Names: EMPAA 10mg
Active Comparator: Metformin 500mg Each participant will receive metformin 1000mg daily for 3 months	Drug: MetFORMIN 500 Mg Oral Tablet; Each participant will receive metformin 1000mg daily for 3 months.; Other Names: Glucophage 500mg

Outcome Measures

Primary Outcome Measures

1. Irregular menstruations assessment [Three months treatment with either empagliflozin 10mg or metformin 1000mg daily]

   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.

Secondary Outcome Measures

1. Body weight [Three months treatment with either empagliflozin 10mg or metformin 1000mg daily]

   assessment of change in Body weight in Kg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

2. Systolic Blood Pressure (SBP) [Three months treatment with either empagliflozin 10mg or metformin 1000mg daily]

   assessment of change in SBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

3. Lipid profile measured through biochemical test [Three months treatment with either empagliflozin 10mg or metformin 1000mg daily]

   assessment of change in Blood Pressure in mg/dL after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

4. Hb1c test [Three months treatment with either empagliflozin 10mg or metformin 1000mg daily]

   assessment of change in Hb1c level in percentage after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

5. fasting blood-glucose measured through biochemical test [Three months treatment with either empagliflozin 10mg or metformin 1000mg daily]

   assessment of fasting blood-glucose in mmol/L after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

6. Diastolic Blood Pressure (DBP) [Three months treatment with either empagliflozin 10mg or metformin 1000mg daily]

   assessment of change in DBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Exclusion Criteria:

1. Women with hypertension history, or

2. suffer in hypothyroidism,

3. Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or androgen- secreting tumors will be streaked from participating.

4. 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.

5. Diabetes, history or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study 7.. Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SINA Yousuf Sb Goth	Karachi	Sindh	Pakistan	74800

Sponsors and Collaborators

• SINA Health Education and Welfare Trust

Investigators

• Principal Investigator: Hina Sharif, PharmD,MSPH, SINA Health Education & Welfare Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hina Sharif, Assistant Manager, SINA Health Education and Welfare Trust
• ClinicalTrials.gov Identifier: NCT06140108
• Other Study ID Numbers: 00002
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 29, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Weight Gain; Metformin; Empagliflozin

Study Results

No Results Posted as of Nov 29, 2023