N-acetyl cysteine plus metformin for women with PCOS

The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients

This trial will test whether adding N-acetyl cysteine to metformin improves hormonal and biochemical measures in women with PCOS.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 20 Years to 45 Years
• Sex: Female
• Sponsor: Cairo University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06836128 on ClinicalTrials.gov

What this trial studies

This phase 3 interventional trial at Kasr El-Ainy Hospital gives women with PCOS a combination of N-acetyl cysteine (NAC) and metformin and monitors changes in hormonal and metabolic laboratory markers. Eligible participants are women aged 20–45 diagnosed with PCOS according to the 2023 international guideline and without diabetes or significant thyroid, kidney, or liver disease. People taking medications that affect carbohydrate metabolism or recent hormonal therapies are excluded. Outcomes focus on biochemical and hormonal parameters with scheduled clinical visits and lab testing during follow-up.

Who should consider this trial

Good fit: Women aged 20–45 with a confirmed diagnosis of PCOS per the 2023 guideline who are not diabetic and have normal thyroid, kidney, and liver function would be ideal candidates.

Not a fit: Patients with diabetes, significant renal or hepatic impairment, thyroid dysfunction, allergy to metformin or NAC, or recent use of interfering medications are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could improve hormonal balance and metabolic markers, potentially easing symptoms such as irregular cycles and infertility.

How similar studies have performed: Smaller trials and meta-analyses have reported that NAC or metformin can improve some PCOS features and early combination studies showed promising but mixed results, so definitive phase 3 data are still limited.

Eligibility criteria

Inclusion Criteria:

1. Female aged 20 to 45 years old.
2. Confirmed diagnosis with PCOS according to the 2023 International Evidence-based Guideline for the Assessment and Management of PCOS.
3. Ability to give informed consent.

Exclusion Criteria:

1. Hypersensitivity to either metformin or NAC.
2. Consumption of medications affecting carbohydrate metabolism, such as insulin, sulfonylureas, and taking hormonal analogues two months prior to enrollment.
3. Hyperprolactinemia, defined as a prolactin level above laboratory reference range.
4. Diabetes mellitus.
5. Thyroid dysfunction, subjects with elevated or low TSH level.
6. Renal impairment where creatinine clearance (CrCl) less than 30 ml/min.
7. Severe hepatic impairment, defined as significant biochemical abnormalities, including hypoalbuminemia and abnormal serum concentration (2-3 times the upper limit of normal), of at least two of the following liver function markers: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT).
8. Active alcohol abuse.
9. History of lactic acidosis during metformin therapy.
10. Active peptic ulcer.
11. Congenital adrenal hyperplasia.
12. Cushing's syndrome.
13. Androgen secreting neoplasia.
14. Patients who were using spironolactone, other anti-androgens, or any form of hormone therapy for the treatment of hirsutism at least 3 months before enrollment in the study.
15. Decompensated heart failure.

Where this trial is running

Cairo

• Kasr El-Ainy hospital — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Marwa R Talat, BPharm

Conditions Polycystic Ovary Syndrome; PCOS; NAC; metformin