Clinical therapeutics · 2023
Clinical Performance and Safety of Vaginal Ovules in the Local Treatment of Nonspecific Vaginitis: A National, Multicentric Clinical Investigation.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Toader Daniela Oana, Olaru Raluca Alexandra, Iliescu Dominic-Gabriel, Petrita Ramona, Calancea Florentina Liliana, Petre Izabella
Аннотация
PURPOSE: Nonspecific vaginitis is a distinct clinical entity with particular microscopic and immunologic features. There is currently no standard of care for women with nonspecific vaginitis. The aim of our study was to assess the change in vaginal symptoms score after 3 months of treatment with an intravaginal medical device in participants with abnormal vaginal discharge and specific signs and symptoms. As secondary objectives, the study analyzed other clinical and microscopic features, such as vaginal discharge aspect, change in vaginal pH, change in vaginal microbiome, and vaginal inflammation.
METHODS: The study population included 47 participants with symptomatic vulvovaginitis, distinct from candidiasis, trichomoniasis, or bacterial vaginosis. The study design included 2 research sites from Romania. The treatment protocol consisted of 1 ovule per day inserted intravaginally during 15 consecutive days. The total study duration was 3 months.
FINDINGS: The intravaginal medical device had a positive impact on the vaginal symptoms score for 72.34% of the study participants. Topical administration of the ovules balanced vaginal pH values and significantly reduced signs of inflammation between study visits.
IMPLICATIONS: This intravaginal medical device had curative effects that support its use as a stand-alone treatment in women with nonspecific vaginitis. A second clinical investigation is ongoing to evaluate the clinical efficacy of the device in postoperative care of cervical and vaginal wounds traumatic or secondary to surgical interventions.
CLINICALTRIALS: gov identifier: NCT04735705.
METHODS: The study population included 47 participants with symptomatic vulvovaginitis, distinct from candidiasis, trichomoniasis, or bacterial vaginosis. The study design included 2 research sites from Romania. The treatment protocol consisted of 1 ovule per day inserted intravaginally during 15 consecutive days. The total study duration was 3 months.
FINDINGS: The intravaginal medical device had a positive impact on the vaginal symptoms score for 72.34% of the study participants. Topical administration of the ovules balanced vaginal pH values and significantly reduced signs of inflammation between study visits.
IMPLICATIONS: This intravaginal medical device had curative effects that support its use as a stand-alone treatment in women with nonspecific vaginitis. A second clinical investigation is ongoing to evaluate the clinical efficacy of the device in postoperative care of cervical and vaginal wounds traumatic or secondary to surgical interventions.
CLINICALTRIALS: gov identifier: NCT04735705.