NCT03117517 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ortega-González C, Luna S, Hernández L, Crespo G, Aguayo P, Arteaga-Troncoso G, Parra A
Responses of serum androgen and insulin resistance to metformin and pioglitazone in obese, insulin-resistant women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Mar;90(3):1360-5. Epub 2004 Dec 14.
Palomba S, Falbo A, Chiossi G, Orio F, Tolino A, Colao A, La Sala GB, Zullo F
Low-grade chronic inflammation in pregnant women with polycystic ovary syndrome: a prospective controlled clinical study. J Clin Endocrinol Metab. 2014 Aug;99(8):2942-51. doi:
Peng Z, Sun Y, Lv X, Zhang H, Liu C, Dai S
Interleukin-6 Levels in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. PLoS One. 2016 Feb 5;11(2):e0148531. doi: 10.1371/journal.pone.0148531. eCollection 2016.
Velazquez EM, Mendoza S, Hamer T, Sosa F, Glueck CJ
Metformin therapy in polycystic ovary syndrome reduces hyperinsulinemia, insulin resistance, hyperandrogenemia, and systolic blood pressure, while facilitating normal menses and pregnancy. Metabolism. 1
Xu X, Du C, Zheng Q, Peng L, Sun Y
Effect of metformin on serum interleukin-6 levels in polycystic ovary syndrome: a systematic review. BMC Womens Health. 2014 Aug 5;14:93. doi: 10.1186/1472-6874-14-93. Review.

Effects of Metformin and Combination of Metformin and Pioglitazone on Plasma Interleukin-6 and Interleukin-8 Levels in Polycystic Ovarian Syndrome

Clinical trial NCT03117517 - References