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New treatment option for Polycystic Ovary Syndrome
Official title The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients
ClinicalTrials.gov ID: NCT06836128
What this study is testing
What is N-acetyl cysteine?
N-acetyl cysteine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for polycystic ovary syndrome.
Also referred to as NAC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 45, women only
You may be able to join 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 likely can't join 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...
- Hyperprolactinemia, defined as a prolactin level above laboratory reference range.
- Diabetes mellitus.
- Thyroid dysfunction, people with elevated or low TSH level.
- Renal impairment where creatinine clearance (CrCl) less than 30 ml/min.
See the full eligibility criteria
- 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.
- 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, people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.