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

Launched by CAIRO UNIVERSITY · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the combined effects of two medications, N-Acetyl Cysteine (NAC) and Metformin, on women with Polycystic Ovary Syndrome (PCOS). PCOS is a common condition that can affect hormone levels, menstrual cycles, and overall health. The researchers want to see how this combination treatment can improve certain biochemical and hormonal measurements in women diagnosed with PCOS.

To participate in the trial, women aged 20 to 45 who have been diagnosed with PCOS according to current guidelines may be eligible. However, those with specific health issues, such as diabetes, thyroid problems, or severe liver or kidney issues, will not be able to participate. The trial is not yet recruiting participants, but once it starts, those who join can expect regular check-ups and assessments to monitor their health and the effects of the medications. This study aims to find a potentially beneficial treatment for managing PCOS symptoms and improving women's health.

Gender

FEMALE

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.