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

Recruiting now · Phase 3

Conditions studied: Polycystic Ovary Syndrome

In brief

The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.

Key facts

Study ID

NCT06836128

Run by

Cairo University

People needed

102

Starts

2025-03-01

Expected to finish

2026-05-01

Last updated by the study team

2025-07-09

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Hypersensitivity to either metformin or NAC.
• Consumption of medications affecting carbohydrate metabolism, such as insulin, sulfonylureas, and taking hormonal analogues two months prior to enrollment.
• Hyperprolactinemia, defined as a prolactin level above laboratory reference range.
• Diabetes mellitus.
• Thyroid dysfunction, subjects with elevated or low TSH level.
• Renal impairment where creatinine clearance (CrCl) less than 30 ml/min.
• 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).
• Active alcohol abuse.
• History of lactic acidosis during metformin therapy.
• Active peptic ulcer.
• Congenital adrenal hyperplasia.
• Cushing's syndrome.
• Androgen secreting neoplasia.
• 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.
• Decompensated heart failure.

Where it is running

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

Full record on ClinicalTrials.gov

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