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No more sleepless nights in perimenopause—an open-label, randomized, parallel-group, active controlled intervention study in perimenopausal women with vasomotor symptoms and insomnia to investigate the efficacy of hormone replacement therapy and cognitive behavioral therapy for the treatment of insomnia: study protocol

Crossref DOI link: https://doi.org/10.1186/s13063-025-09366-9

Published Online: 2025-12-30

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Pavicic, Elena

Stute, Petra

Rudzik, Franziska

Urech, Antoine

Lozza-Fiacco, Serena
Funding

Funding for this research was provided by:

Gottfried und Julia Bangerter-Rhyner-Stiftung
License Information

Text and Data Mining valid from 2025-12-30

Version of Record valid from 2026-01-30
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Article History

Received: 6 September 2024

Accepted: 3 December 2025

First Online: 30 December 2025

Declarations

:

: The study has been approved by the Swiss Ethics Committee on 16 May 2023 (No. 2023–00209) (Supplementary file 1). Written informed consent will be obtained from all participants prior to participation in the study in accordance with the Declaration of Helsinki and the Human Research Act [ , ]. This study will be conducted in accordance with all applicable ethical, legal, and regulatory requirements [ – ].

: Not applicable. This study does not involve the publication of any identifiable patient/participant data or images.

: The authors declare that they have no competing interests.

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