دورية أكاديمية
An effective non-hormonal option with high tolerability for mild to moderate symptoms of vaginal dryness associated with menopause.
| العنوان: | An effective non-hormonal option with high tolerability for mild to moderate symptoms of vaginal dryness associated with menopause. |
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| المؤلفون: | Eichler S; Dr. August Wolff GmbH & Co. KG Arzneimittel, 33611 Bielefeld, Germany. Electronic address: susann.eichler@drwolffgroup.com., Panz M; Dr. August Wolff GmbH & Co. KG Arzneimittel, 33611 Bielefeld, Germany., Harder A; Dr. August Wolff GmbH & Co. KG Arzneimittel, 33611 Bielefeld, Germany., Masur C; Dr. August Wolff GmbH & Co. KG Arzneimittel, 33611 Bielefeld, Germany., Häuser M; Dr. August Wolff GmbH & Co. KG Arzneimittel, 33611 Bielefeld, Germany., Wiesche ESZ; Dr. August Wolff GmbH & Co. KG Arzneimittel, 33611 Bielefeld, Germany. |
| المصدر: | Maturitas [Maturitas] 2024 Jul; Vol. 185, pp. 107978. Date of Electronic Publication: 2024 Mar 29. |
| نوع المنشور: | Journal Article; Clinical Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier/North Holland Biomedical Press Country of Publication: Ireland NLM ID: 7807333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-4111 (Electronic) Linking ISSN: 03785122 NLM ISO Abbreviation: Maturitas Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Limerick : Elsevier/North Holland Biomedical Press Original Publication: Amsterdam, Elsevier/North Holland Biomedical Press. |
| مواضيع طبية MeSH: | Vaginal Diseases*/drug therapy , Vaginal Diseases*/therapy , Quality of Life* , Dyspareunia*/drug therapy , Dyspareunia*/therapy , Dyspareunia*/etiology , Vagina*/drug effects , Vagina*/pathology , Menopause* , Pessaries*, Humans ; Female ; Middle Aged ; Aged ; Prospective Studies ; Surveys and Questionnaires ; Severity of Illness Index ; Postmenopause ; Treatment Outcome |
| مستخلص: | Objectives: The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause. Study Design: Seventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial. Main Outcome Measures: During the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied. Results: A rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as "good to very good" by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred. Conclusion: Overall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active. Clinicaltrials: gov identifier NCT05211505. Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: all authors are employees of Dr. August Wolff GmbH & Co. KG Arzneimittel, 33611 Bielefeld, Germany. (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.) |
| فهرسة مساهمة: | Keywords: (Post)menopause; Atrophic vaginitis; Dyspareunia; Non-hormonal vaginal remedy; Vaginal dryness |
| سلسلة جزيئية: | ClinicalTrials.gov NCT05211505 |
| تواريخ الأحداث: | Date Created: 20240407 Date Completed: 20240601 Latest Revision: 20240614 |
| رمز التحديث: | 20240614 |
| DOI: | 10.1016/j.maturitas.2024.107978 |
| PMID: | 38583316 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1873-4111 |
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| DOI: | 10.1016/j.maturitas.2024.107978 |