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

Comprising the effect of combination therapy metformin plus empagliflozin versus metformin on clinical symptoms, hormonal profiles, and biomarkers of inflammation in women with polycystic ovarian syndrome (PCOS) in Semnan

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231207060284N1

Enrollment

Registered

2024-01-29

Start date

2024-01-21

Completion date

Unknown

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: receiving metformin with a dose of 1500 mg per day for 12 weeks. Intervention 2: Intervention group: receiving Empagliflozin with a dose of 25 mg per day plus me

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactForugh Foruzandeh

Semnan University of Medical Sciences

fforuzandeh@yahoo.com+98 23 3934 6479

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026