Morga, Antonia http://orcid.org/0009-0008-6671-5056
Zimmermann, Lisa
Valluri, Udaya
Siddiqui, Emad
McLeod, Lori
Bender, Randall H.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Validation and Application of Thresholds to Define Meaningful Change in Vasomotor Symptoms Frequency: Analysis of Pooled SKYLIGHT 1 and 2 Data
https://doi.org/10.1007/s12325-024-02849-2
Psychometric Evaluation of the MENQOL Instrument in Women Experiencing Vasomotor Symptoms Associated with Menopause
https://doi.org/10.1007/s12325-024-02787-z
▼Fezolinetant for menopausal vasomotor symptoms
https://doi.org/10.1136/dtb.2024.000025
Documents that mention this clinical trial
Validation and Application of Thresholds to Define Meaningful Change in Vasomotor Symptoms Frequency: Analysis of Pooled SKYLIGHT 1 and 2 Data
https://doi.org/10.1007/s12325-024-02849-2
Psychometric Evaluation of the MENQOL Instrument in Women Experiencing Vasomotor Symptoms Associated with Menopause
https://doi.org/10.1007/s12325-024-02787-z
▼Fezolinetant for menopausal vasomotor symptoms
https://doi.org/10.1136/dtb.2024.000025
Funding for this research was provided by:
Astellas Pharma US
Article History
Received: 7 December 2023
Accepted: 19 March 2024
First Online: 22 May 2024
Declarations
:
: Antonia Morga, Lisa Zimmermann, Udaya Valluri, and Emad Siddiqui are employees of Astellas Pharma. Lori McLeod and Randall H. Bender are full-time employees of RTI Health Solutions; their compensation is unconnected to the projects on which they work.
: The SKYLIGHT 1 and 2 studies were conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and International Council for Harmonisation guidelines. An independent ethics committee or institutional review board reviewed the ethical, scientific, and medical appropriateness of the study at each site before data collection. The independent ethics committees or institutional review boards that were involved in reviewing the SKYLIGHT 1 and 2 studies were Advarra Headquarters (USA); Advarra Canada (Canada); CEI, Hospital 12 de Octubre, Centro Actividades Ambulatoria (Spain); Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottság (ETT-KFEB; Hungary); Ethics Committee of Communal Nonprofit Enterprise Maternity Hospital #4 of Zaporizhzhya City Council (Ukraine); Eticka komise FN Brno (Czechia); Ethics Committee for Clinical Research, Pauls Stradins Clinical University Hospital Development Society (Latvia); Komisja Bioetyczna, przy Okregowej Radzie Lekarskiej, Wielkopolskiej Izby Lekarskiej w Poznaniu (Poland); and South Central–Hampshire B Research Ethics Committee; HSC A, Office for Research Ethics Committees Northern Ireland; and East Midlands–Nottingham 2 Research Ethics Committee (UK). Signed informed consent forms were obtained from the participants before any study-related procedures were performed.