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NCT06836128CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
102 (actual)
First submitted
30 Jan 2025
Start date
1 Mar 2025
Primary completion date
30 Mar 2026
Lead sponsor
Cairo University
NCT number
NCT06836128

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 102
  • From 1 Mar 2025 to the primary completion date, 30 Mar 2026
  • 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

  • Consumption of medications affecting carbohydrate metabolism, such as insulin, sulfonylureas, and taking hormonal analogues two months prior to enrollment.
  • 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.

Other illness

  • Hypersensitivity to either metformin or NAC.
  • Diabetes mellitus.
  • History of lactic acidosis during metformin therapy.
  • Active peptic ulcer.
  • Cushing's syndrome.
  • Decompensated heart failure.

Lab values

  • Hyperprolactinemia, defined as a prolactin level above laboratory reference range.
  • 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).

Other

  • Thyroid dysfunction, subjects with elevated or low TSH level.
  • Active alcohol abuse.
  • Congenital adrenal hyperplasia.
  • Androgen secreting neoplasia.

Who the study is looking for

  • 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.

Age in the registry: 20 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kasr El-Ainy hospital
Coordinator of this site? Confirm its status
CairoEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.