NCT06836128 The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients
| NCT ID | NCT06836128 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cairo University |
| Condition | Polycystic Ovary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 102 participants in total. It began in 2025-03-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.
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.
Contact & Investigator
Samar F Farid, PhD
STUDY DIRECTOR
Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University
Frequently Asked Questions
Who can join the NCT06836128 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 45 Years, studying Polycystic Ovary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06836128 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 102 participants.
Is NCT06836128 currently recruiting?
Yes, NCT06836128 is actively recruiting participants. Contact the research team at marwa.rafat@pharma.cu.edu.eg for enrollment information.
Where is the NCT06836128 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06836128 clinical trial?
NCT06836128 is sponsored by Cairo University. The principal investigator is Samar F Farid, PhD at Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University. The trial plans to enroll 102 participants.