Updates are available Correction dated 2024-04-23
Click to view Correction: https://doi.org/10.1007/s12325-024-02847-4
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Authors
Schultz, Neil M.
Morga, Antonia https://orcid.org/0009-0008-6671-5056
Siddiqui, Emad
Rhoten, Stephanie E.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04003155 at ClinicalTrials.govnct04003142 at ClinicalTrials.govDocuments 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
Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies
https://doi.org/10.1007/s12325-024-03073-8
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
Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies
https://doi.org/10.1007/s12325-024-03073-8
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
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Funding
Funding for this research was provided by:
Astellas Pharma US
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More Information
Article History
Received: 25 September 2023
Accepted: 15 January 2024
First Online: 24 February 2024
Change Date: 23 April 2024
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s12325-024-02847-4
Declarations
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: All authors have received support for medical writing. Neil M. Schultz, Antonia Morga, and Emad Siddiqui are employees of Astellas Pharma Inc. Stephanie E. Rhoten received consulting fees from IQVIA.
: This analysis used data that were acquired from the SKYLIGHT 1 and 2 studies. These 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.
