Lukes, Andrea
Migoya, Elizabeth http://orcid.org/0000-0002-7635-4417
Johnson, Brendan http://orcid.org/0000-0003-3737-7146
Lee, Tien-Yi http://orcid.org/0000-0002-2238-5672
Li, Yulan
Arjona Ferreira, Juan Camilo http://orcid.org/0000-0002-4514-4046
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Randomized Open-Label Study of Relugolix Alone or Relugolix Combination Therapy in Premenopausal Women
https://doi.org/10.1007/s40262-023-01269-9
Article History
Accepted: 25 May 2023
First Online: 26 June 2023
Declarations
:
: This study was sponsored by Myovant Sciences GmbH, Basel, Switzerland. Myovant contracted DaVita and West Coast Clinical Trials Global to conduct the study and QPS to analyze the pharmacokinetic samples. Myovant funded the manuscript development and open access publication.
: EM, TYL, YL, and JCAF are employees of Myovant Sciences and own stock/options in the company. AL has received grants, consulting fees, or honoraria from Myovant Sciences and payment for lectures from Myovant Sciences and AbbVie. AL is a principal investigator for several companies including: AbbVie, Bayer, Merck, Myovant, Organon, NIH, Estetra SRL and Lundbeck LLC. BJ is an employee and stockholder of Roivant Sciences, the parent company of Myovant Sciences. BJ also holds stock options in Myovant Sciences and is a co-inventor on some Myovant Sciences relugolix patents.
: Independent ethics committee review and approval of the study protocol, informed consent forms, and other information requiring pre-approval were provided by an institutional review board (IntegReview, Austin, TX, USA). This study was performed in compliance with International Council for Harmonisation Good Clinical Practices, with US 21 Code of Federal Regulations 312.3(b), and with the ethical principles of the Declaration of Helsinki 2008.
: All participants provided written informed consent before the initiation of study procedures.
: Not applicable (no data are reported that could identify individuals).
: Data from this article will not be deposited in a data repository.
: Not applicable.
: Study conception: BJ. Study design: BJ. Data interpretation: AL, EM, BJ, T-YL, YL, JCAF. Manuscript drafting/revision: AL, EM, BJ, T-YL, YL, JCAF. Approval of final manuscript: AL, EM, BJ, T-YL, YL, JCAF. Agreement to take public responsibility for appropriate portions of the content: AL, EM, BJ, T-YL, YL, JCAF.