NCT07380841Completed
Metformin vs Inositol vs Diet vs Combination Therapy in PCOS
Comparative Effectiveness of Metformin, Inositol, Dietary Restriction, and Combination Therapy in Polycystic Ovary Syndrome: A 12-Week Prospective Randomized Study
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
Polycystic ovary syndrome (PCOS) is a common condition that can cause irregular periods, excess male-type hormones, weight gain, and insulin resistance. This study will compare four commonly used approaches for PCOS management: metformin, inositol, a calorie-restricted diet, and a combination of all three. A total of 192 women aged 18-35 years with PCOS (diagnosed using Rotterdam criteria) will be randomly assigned to one of four groups for 12 weeks: (A) metformin, (B) myo-inositol plus D-chiro-inositol, (C) calorie-restricted diet, or (D) combination therapy (metformin + inositol + diet). The study will assess changes in body weight, body mass index (BMI), waist circumference, fasting glucose, fasting insulin, insulin resistance (HOMA-IR), and menstrual regularity. Hormonal measures and safety outcomes will also be evaluated. The goal is to determine which approach provides the greatest overall metabolic and reproductive benefit in women with PCOS.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 192 (actual)
- First submitted
- 24 Jan 2026
- Start date
- 21 May 2025
- Primary completion date
- 11 Nov 2025
- Lead sponsor
- Islamabad Medical and Dental College
- NCT number
- NCT07380841
What you commit to
- Study type: Interventional
- Participants enrolled: 192
- From 21 May 2025 to the primary completion date, 11 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of metformin, inositol, hormonal therapy, or weight-loss drugs within the last 3 months.
Other illness
- Pregnancy or lactation. Known diabetes mellitus, thyroid disease, hyperprolactinemia, Cushing's syndrome, or other endocrine disorders.
- History of renal, hepatic, or cardiovascular disease. Known hypersensitivity to metformin or inositol. Participation in another clinical trial within the last 3 months. Any serious medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation.
Who the study is looking for
- Body mass index (BMI) ≥ 18.5 kg/m². Willing to participate and provide written informed consent. Willing to comply with study procedures and follow-up visits.
- \-
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pakistan Institute of Health Sciences / Islamabad Medical and Dental College (IMDC) Coordinator of this site? Confirm its status | Islamabad | Pakistan | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.