The combined effect of N-Acetyl cysteine and metformin in polycystic ovary syndrome patients
NCT ID NCT06836128
First seen Oct 21, 2026 ยท Last updated Oct 21, 2026
Summary
The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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102 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kasr El-Ainy hospital
Cairo, Egypt
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Other studies related to the condition(s) this trial covers.
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