drugset / Trial / NCT06836128
The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.
Timeline
- Start
- 2025-03-01
- Primary completion
- 2026-02-01
- Completion
- 2026-05-01
Publications
- Background Tiganis T. Reactive oxygen species and insulin resistance: the good, the bad and the ugly. Trends Pharmacol Sci. 2011 Feb;32(2):82-9. doi: 10.1016/j.tips.2010.11.006. Epub 2010 Dec 14.
- Background Pei Y, Liu H, Yang Y, Yang Y, Jiao Y, Tay FR, Chen J. Biological Activities and Potential Oral Applications of N-Acetylcysteine: Progress and Prospects. Oxid Med Cell Longev. 2018 Apr 22;2018:2835787. doi: 10.1155/2018/2835787. eCollection 2018.
- Background Yifu P. A review of antioxidant N-acetylcysteine in addressing polycystic ovary syndrome. Gynecol Endocrinol. 2024 Dec;40(1):2381498. doi: 10.1080/09513590.2024.2381498. Epub 2024 Jul 22.
- Background Christ JP, Cedars MI. Current Guidelines for Diagnosing PCOS. Diagnostics (Basel). 2023 Mar 15;13(6):1113. doi: 10.3390/diagnostics13061113.
- Background Gayatri K, Kumar JS, and Kumar BB. Metformin and N-acetyl cysteine in polycystic ovarian syndrome--a comparative study. Indian Journal of Clinical Medicine. 2023;15;24(18):14126. doi.org/10.1177/117739361000100002
- Background Scholze A, Rinder C, Beige J, Riezler R, Zidek W, Tepel M. Acetylcysteine reduces plasma homocysteine concentration and improves pulse pressure and endothelial function in patients with end-stage renal failure. Circulation. 2004 Jan 27;109(3):369-74. doi: 10.1161/01.CIR.0000109492.65802.AD. Epub 2004 Jan 19.
- Background Fulghesu AM, Ciampelli M, Muzj G, Belosi C, Selvaggi L, Ayala GF, Lanzone A. N-acetyl-cysteine treatment improves insulin sensitivity in women with polycystic ovary syndrome. Fertil Steril. 2002 Jun;77(6):1128-35. doi: 10.1016/s0015-0282(02)03133-3.
- Background De Mattia G, Bravi MC, Laurenti O, Cassone-Faldetta M, Proietti A, De Luca O, Armiento A, Ferri C. Reduction of oxidative stress by oral N-acetyl-L-cysteine treatment decreases plasma soluble vascular cell adhesion molecule-1 concentrations in non-obese, non-dyslipidaemic, normotensive, patients with non-insulin-dependent diabetes. Diabetologia. 1998 Nov;41(11):1392-6. doi: 10.1007/s001250051082.
- Background Brown J, Farquhar C. Clomiphene and other antioestrogens for ovulation induction in polycystic ovarian syndrome. Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD002249. doi: 10.1002/14651858.CD002249.pub5.
- Background Costello M, Garad R, Hart R, Homer H, Johnson L, Jordan C, Mocanu E, Qiao J, Rombauts L, Teede HJ, Vanky E, Venetis C, Ledger W. A Review of First Line Infertility Treatments and Supporting Evidence in Women with Polycystic Ovary Syndrome. Med Sci (Basel). 2019 Sep 10;7(9):95. doi: 10.3390/medsci7090095.
- Background Martin KA, Anderson RR, Chang RJ, Ehrmann DA, Lobo RA, Murad MH, Pugeat MM, Rosenfield RL. Evaluation and Treatment of Hirsutism in Premenopausal Women: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1233-1257. doi: 10.1210/jc.2018-00241.
- Background Greff D, Juhasz AE, Vancsa S, Varadi A, Sipos Z, Szinte J, Park S, Hegyi P, Nyirady P, Acs N, Varbiro S, Horvath EM. Inositol is an effective and safe treatment in polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials. Reprod Biol Endocrinol. 2023 Jan 26;21(1):10. doi: 10.1186/s12958-023-01055-z.
- Background Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256.
- Background Dason ES, Koshkina O, Chan C, Sobel M. Diagnosis and management of polycystic ovarian syndrome. CMAJ. 2024 Jan 28;196(3):E85-E94. doi: 10.1503/cmaj.231251. No abstract available.
- Background Schuring AN, Schulte N, Sonntag B, Kiesel L. Androgens and insulin--two key players in polycystic ovary syndrome. Recent concepts in the pathophysiology and genetics of polycystic ovary syndrome. Gynakol Geburtshilfliche Rundsch. 2008;48(1):9-15. doi: 10.1159/000111465. Epub 2008 Jan 17.
- Background Zeber-Lubecka N, Ciebiera M, Hennig EE. Polycystic Ovary Syndrome and Oxidative Stress-From Bench to Bedside. Int J Mol Sci. 2023 Sep 15;24(18):14126. doi: 10.3390/ijms241814126.
- Background International Evidence-Based Guideline for the Assessment. 2023, www.monash.edu/__data/assets/pdf_file/0003/3379521/Evidence-Based-Guidelines-2023.pdf.
- Background Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.
- Background Skiba MA, Islam RM, Bell RJ, Davis SR. Understanding variation in prevalence estimates of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2018 Nov 1;24(6):694-709. doi: 10.1093/humupd/dmy022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | — |
| Subject | N-acetylcysteine | Small molecule | 600 mg | — |