Skip to content

Effect of metformin versus dapagliflozin in treatment of polycystic ovary syndrom.

Effect of sodium-glucose co-transporter inhibitor on metabolic and hormonal profiles in polycystic ovary syndrome

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240520061850N1
Enrollment
100
Registered
2024-11-09
Start date
2024-06-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Polycystic ovary syndrome Based on Rotterdam Criteria. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group :Treatment of women with polycystic ovary syndrome aged 18-45 with a body mass index greater than or equal to 25, with metformin 500 mg TID for 3 months. Metformin i

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women aged 18-45 with polycystic ovary syndrome with body mass index more than 25

Exclusion criteria

Exclusion criteria: Cushing syndrome inadequately controlled thyroid disease. androgen-secreting tumor pregnancy or intention to become pregnant Breast feeding documented use of oral hormonal contraceptives and hormone-releasing implants, clomiphene citrate or estrogen modulators, gonadotropin-releasing hormone (GnRH) modulators diagnosis of diabetes and use of antidiabetic agent congenital adrenal hyperplasia due to 21-hydroxilase defficiency hyperprolactinemia, age45 year,

Design outcomes

Primary

MeasureTime frame
The percentage of people with fasting blood sugar >/equal to 100. Timepoint: Measuring fasting blood sugar at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling.;Blood pressure measurement. Timepoint: Measuring blood pressure at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Sphygmomonometer.;Fasting plasma lipid level. Timepoint: Fasting plasma lipid measurement at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling.;Fasting plasma insulin level. Timepoint: Fasting plasma insulin level measurement at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling.;Fasting plasma androstenedione level. Timepoint: Fasting plasma androstenedione level measurement at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling.;Total plasma testosterone. Timepoint: Fasting plasma testosterone level measurement at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling.;C-reactive protein plasma level. Timepoint: Measuring the plasma level of C-reactive protein at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling.;Measurement of waist/Hip ratio. Timepoint: Measuring waist/Hip ratio at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Meter.;Body mass index. Timepoint: Measuring body mass index at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Meter and scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarnaz Kamali Haghighi Shirazi

Shiraz University of Medical Sciences

F.kamali85@gmail.com+98 71 3647 4332

Outcome results

None listed

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