NCT02599077 - 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)

Burney RO, Giudice LC
Pathogenesis and pathophysiology of endometriosis. Fertil Steril. 2012 Sep;98(3):511-9. doi: 10.1016/j.fertnstert.2012.06.029. Review.
Eskenazi B, Warner ML
Epidemiology of endometriosis. Obstet Gynecol Clin North Am. 1997 Jun;24(2):235-58. Review.
Giudice LC
Clinical practice. Endometriosis. N Engl J Med. 2010 Jun 24;362(25):2389-98. doi: 10.1056/NEJMcp1000274. Review.
Harada T, Momoeda M, Taketani Y, Aso T, Fukunaga M, Hagino H, Terakawa N
Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis--a randomized, double-blind, multicenter, controlled trial. F
Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT; World Endometriosis Research Foundation Global Study of Women's Health consortium
. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011 Aug;96(2):366-373.e8. doi: 10.1016/j.fertnstert.2011.05.090.
Practice Committee of the American Society for Reproductive Medicine
. Endometriosis and infertility: a committee opinion. Fertil Steril. 2012 Sep;98(3):591-8.
Ruan X, Seeger H, Mueck AO
The pharmacology of dienogest. Maturitas. 2012 Apr;71(4):337-44. doi: 10.1016/j.maturitas.2012.01.018. Review.

Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas in Women With Diameters Smaller Than 4 Centimeters Thereof, at University Hospital Fundación Santa Fe de Bogota, Between the Years 2015-2017

Details for clinical trial NCT02599077

Clinical trial NCT02599077 - References