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Erschienen in: Wiener Medizinische Wochenschrift 7-8/2017

01.05.2017 | main topic

Clinical trial shows lasting function of a new moisturizing cream against vaginal dryness

verfasst von: Hans-Heinrich Henneicke-von Zepelin, Ragna Williams, Wiebke Havemeister, Walter Wigger-Alberti, Klaus-Ulrich Nolte

Erschienen in: Wiener Medizinische Wochenschrift | Ausgabe 7-8/2017

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Summary

Vaginal dryness and associated symptoms may occur in women of any age and are a frequent burden after menopause. The North American Menopause Society recommends long-acting non-hormonal vaginal creams as first-line therapy. A new type of such creams was developed (Remifemin® FeuchtCreme in Austria and Germany). This hormone-free cream contains hamamelis virginiana distillate and well-established vaginal cream ingredients. We explored its physical function and tolerability in an open interventional clinical trial. 20 postmenopausal women (54 to 76 years, median 60) treated their vaginal dryness using this cream once daily for 7 days and reported about their symptoms before, 4 to 8 h after first and 14 to 22 h after last application. A physician assessed tolerability and local physical function. All patients completed the study. Local physical function significantly improved from dryness at baseline (mean 4.0 ± SD 1.8) to a normal moisture level, on average (6.3 ± 2.1 after first, 6.7 ± 2.1 after last application, p = 0.0001). Subjective assessment of a feeling vaginal dryness showed a significant improvement at both times (p = 0.0001). Onset and duration of feeling moisturized were reported to be 0 to 2 min and 11.3 ± 6.9 h after application. All women reported vaginal dryness at baseline. 55 and 80% of patients reported no dryness after first application and at the end of the investigation. The cream was seen at the application site for up to 21 h. Tolerability assessments did not reveal any relevant change over time. There were four adverse events in 4 patients, all not serious and of mild intensity: urinary urgency (2), diarrhoea (1) and mild spotting after first application (1). The latter was caused by the dry surface of the applicator and was avoided by moisturizing the surface of the applicator at subsequent applications. In conclusion, these study results indicate a well-tolerated and long-acting function of this new vaginal moisturizing cream. Further clinical research in more patients will follow.
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Metadaten
Titel
Clinical trial shows lasting function of a new moisturizing cream against vaginal dryness
verfasst von
Hans-Heinrich Henneicke-von Zepelin
Ragna Williams
Wiebke Havemeister
Walter Wigger-Alberti
Klaus-Ulrich Nolte
Publikationsdatum
01.05.2017
Verlag
Springer Vienna
Erschienen in
Wiener Medizinische Wochenschrift / Ausgabe 7-8/2017
Print ISSN: 0043-5341
Elektronische ISSN: 1563-258X
DOI
https://doi.org/10.1007/s10354-016-0536-0

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