Susann Eichler, Mareike Panz, Anastasia Harder, Clarissa Masur, Manuel Häuser, Erik Schulze zur Wiesche
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引用次数: 0
Abstract
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.
期刊介绍:
Maturitas is an international multidisciplinary peer reviewed scientific journal of midlife health and beyond publishing original research, reviews, consensus statements and guidelines, and mini-reviews. The journal provides a forum for all aspects of postreproductive health in both genders ranging from basic science to health and social care.
Topic areas include:• Aging• Alternative and Complementary medicines• Arthritis and Bone Health• Cancer• Cardiovascular Health• Cognitive and Physical Functioning• Epidemiology, health and social care• Gynecology/ Reproductive Endocrinology• Nutrition/ Obesity Diabetes/ Metabolic Syndrome• Menopause, Ovarian Aging• Mental Health• Pharmacology• Sexuality• Quality of Life