Comprising the effect of combination therapy metformin plus empagliflozin versus metformin in women with polycystic ovarian syndrome (PCOS)

Phase 2

Recruiting

• Conditions: polycystic ovarian syndrome.; Polycystic ovarian syndrome; E28.2

• Registration Number: IRCT20231207060284N1
• Lead Sponsor: Semnan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

Polycystic ovary syndrome based on PCOS diagnostic criteria based on the Rotterdam conference of European Society of Human Reproduction and Embryology and American Society for Reproductive Medicine
above 18-year-old age
The presence of at least 2 of the 3 main criteria: 1) anovulation or oligo-ovulation 2) biochemical or clinical signs of hyperandrogenism and 3) polycystic ovary morphology (PCOM) on ultrasonography (either 12 or more follicles measuring 2-9 mm in diameter and/or an increased ovarian volume >10 cm3).

Exclusion Criteria

Pregnancy
Diabetes
The use of hormonal contraceptives and hormone-releasing implants (within 6 weeks before entering the study)
The use of anti-diabetic medications
The use of anti-androgen agents (within 3 months prior to entry)
The use of insulin sensitizing medications
The use of clomiphene citrate or estrogen modulators
The use of gonadotropin-releasing hormone
Thyroid and adrenal dysfunction
Frequent urinary tract infections or gastrointestinal surgery
Known hypersensitivity to the investigational medicinal product
Hyperprolactinemia

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum level of IL-18. Timepoint: Before treatment and 12 weeks after treatment. Method of measurement: ELISA Kit.;Serum level of TNF-a. Timepoint: Before treatment and 12 weeks after treatment. Method of measurement: ELISA Kit.;Insulin resistance (IR). Timepoint: Before treatment and 12 weeks after treatment. Method of measurement: HOMA-IR index.;Luteinizing hormone. Timepoint: Before treatment and 12 weeks after treatment. Method of measurement: Chemiluminescence-immunoassay.;Follicle-stimulating hormone. Timepoint: Before treatment and 12 weeks after treatment. Method of measurement: Chemiluminescence-immunoassay.