CompletedNot Applicable

Effect of Pioglitazone vs Metformin on Clinical, Biochemical and Hormonal Parameters of Insulin Resistant PCOS

Bangladesh60 participantsStarted 2024-08-12

Plain-language summary

Women with PCOS with HOMA-IR \>2 fulfilling inclusion and exclusion criteria are randomly allocated into two groups: group A: pioglitazone 30 mg once daily and group B: Metformin 500 thrice daily for 3 months.Each group contains 30 participants. Outcome variables are measured after 3 months.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Diagnosed case of PCOS patients according to Rotterdam criteria * HOMA-IR \>2 (Hydrie et al., 2012) * Age: 18-35 years * BMI: 18.5 -27.5 kg/m² Exclusion criteria: * Presence of any endocrine disorder (hyperthyroidism, hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, hyperprolactinaemia, diabetes mellitus). * Presence of any medical comorbidity (renal, hepatic and cardiovascular disease) * Any medication in the last three months which would affect insulin resistance (metformin, oral contraceptive pill) * Any contraindications to Pioglitazone (Patients with a known hypersensitivity to pioglitazone or any of its components, Diabetic ketoacidosis or type 1 diabetes) or Metformin (severe chronic diseases e.g. hepatic, renal and cardiac failure or acute complications of diabetes e.g. ketoacidosis and hyperosmolar state).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

biochemical parameters of insulin resistant PCOS

Timeframe: baseline to 3 months

clinical parameter

Timeframe: 3 months

hormonal parameter

Timeframe: 3 months

Trial details

NCT IDNCT07472179

SponsorMst.Sumyara Khatun

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-12

View on ClinicalTrials.gov More PCOS(Insulin Resistant) trials