NCT04539587 - 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)

Cavalheiro JA, Bittelbrunn A, Menke CH, Biazús JV, Xavier NL, Cericatto R, Schuh F, Pinheiro CV, Passos EP
Sexual function and chemotherapy in postmenopausal women with breast cancer. BMC Womens Health. 2012 Sep 11;12:28.
Dow J, Kennedy Sheldon L
Breast Cancer Survivors and Sexuality: A Review of the Literature Concerning Sexual Functioning, Assessment Tools, and Evidence-Based Interventions. Clin J Oncol Nurs. 2015 Aug;19(4):456-61. doi: 10.1188/15.CJON.456-461. Review.
Frechette D, Paquet L, Verma S, Clemons M, Wheatley-Price P, Gertler SZ, Song X, Graham N, Dent S
The impact of endocrine therapy on sexual dysfunction in postmenopausal women with early stage breast cancer: encouraging results from a prospective study. Breast Cancer Res Treat. 2013 Aug;141(1):111-7. doi: 10.1007/s10549-013-2659-y. Epub 2013 Aug 14.
Hummel SB, van Lankveld JJDM, Oldenburg HSA, Hahn DEE, Kieffer JM, Gerritsma MA, Kuenen MA, Bijker N, Borgstein PJ, Heuff G, Lopes Cardozo AMF, Plaisier PW, Rijna H, van der Meij S, van Dulken EJ, Vrouenraets BC, Broomans E, Aaronson NK
Efficacy of Internet-Based Cognitive Behavioral Therapy in Improving Sexual Functioning of Breast Cancer Survivors: Results of a Randomized Controlled Trial. J Clin Oncol. 2017 Apr 20;35(12):1328-1340. doi: 10.1200/JCO.2016.69.6021. Epub 2017 Feb 27.

Sexual Quality of Life in Women During the First Year of Adjuvant Hormonal Treatment for Breast Cancer: a Prospective Longitudinal Study

Clinical trial NCT04539587 - References