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Clinical Trial
. 2025 Sep:200:108670.
doi: 10.1016/j.maturitas.2025.108670. Epub 2025 Jul 23.

PERCEIVE: A retrospective, qualitative interview-based study of the impact of vasomotor symptoms associated with menopause on the lives of individuals who are not suitable candidates for hormone therapy

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Free article
Clinical Trial

PERCEIVE: A retrospective, qualitative interview-based study of the impact of vasomotor symptoms associated with menopause on the lives of individuals who are not suitable candidates for hormone therapy

Angelica Lindén Hirschberg et al. Maturitas. 2025 Sep.
Free article

Abstract

Objectives: PERCEIVE collected insights from individuals for whom menopausal hormone therapy was unsuitable for addressing the effects and management of menopausal vasomotor symptoms.

Study design: Interviews were conducted with participants exiting DAYLIGHT (NCT05033886), a phase 3b trial of fezolinetant. DAYLIGHT enrolled menopausal women aged 40-65 years who sought relief from moderate to severe vasomotor symptoms but had contraindications/precautions to, prior discontinuation of, or aversion to using hormone therapy.

Main outcome measures: Menopausal symptoms, impacts of vasomotor symptoms, treatment use and satisfaction, and treatment barriers.

Results: Thirty-two participants were interviewed (mean age 57 years; mean age at onset of vasomotor symptoms 48 years; 78 % employed). Common symptoms were hot flashes (100 %), perspiration (81 %), and night sweats (44 %). Impacts of vasomotor symptoms included difficulty sleeping (94 %), tiredness from sleep interruptions (75 %), work impairment (75 %), emotionality (56 %), need to change clothes (56 %), and poor sleep quality (53 %). A quarter had never had their vasomotor symptoms treated; others had tried natural remedies (53 %), hormone therapy (31 %), acupuncture (9 %), over-the-counter agents (9 %), antidepressants (6 %), vaginal ring (3 %), and psychological therapy (3 %). Hormone therapy had the highest satisfaction rating (mean 3.7 on a 5-point scale); participants were slightly dissatisfied with natural remedies and antidepressants (mean 2.0 each). Treatment barriers included ineligibility and side effects (hormone therapy), ineffectiveness and limited access (nonhormonal agents), cost, menopause stigma, and lack of support from healthcare providers.

Conclusions: Vasomotor symptoms associated with menopause negatively impacted daily life, particularly sleep, among participants unsuited to hormone therapy. Many sought nonhormonal treatments but found them ineffective, costly, and unsatisfactory.

Keywords: Hot flashes; Menopause; Patient satisfaction; Qualitative research; Sleep; Vasomotor symptoms.

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Conflict of interest statement

Declaration of competing interest Angelica Lindén Hirschberg reports serving on an advisory board and/or as a speaker for Astellas, Bayer, Besins Healthcare Ireland Ltd., and Gedeon Richter and receiving an unrestricted research grant from Avia Pharma AB and Besins Healthcare Ireland Ltd. Antonia Morga, Franck Bruon, and Karla Martins are employees of Astellas Pharma Europe Ltd. Arianne Schild is an employee of Astellas Pharma Inc. Emily Hawryluk and Betsy Williams are employees of IQVIA, and Keena Roberts was an employee of IQVIA at the time of this study; IQVIA received funding from Astellas for the conduct of the study. Rossella E. Nappi reports past financial relationships (lecturer, member of advisory boards, and/or consultant) with Boehringer Ingelheim, Eli Lilly, Endoceutics, HRA Pharma, Palatin Technologies, Pfizer, Procter & Gamble, Teva Women's Health, and Zambon; maintains ongoing relationships with Abbott, Astellas, Bayer HealthCare, Besins Healthcare, Biocodex, Exeltis, Fidia, Gedeon Richter, Merck & Co, Novo Nordisk, Organon, Shionogi, Theramex, Viatris, and Vichy Laboratories; and serves as President of the International Menopause Society.

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