Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis

Status Recruiting

Clinical Trial Summary

Candidiasis is an infection caused by a yeast (a type of fungus) called Candida. Candidiasis in the vagina is commonly called a "vaginal yeast infection." Another names for this infection is "vaginal candidiasis". The symptoms of vaginal candidiasis include: Vaginal itching or soreness, Pain during sexual intercourse, Pain or discomfort when urinating and Abnormal vaginal discharge. VagiVitalAC is a modified version of the existing gel VagiVital, formulated to act as a treatment for fungal infections. This clinical investigation is a two-part study consisting of a pilot part followed by a randomized part. The aim of the pilot part is to evaluate if VagiVitalAC is able to cure the vulvovaginal candidiasis in at least 70% of the patients after 7 days treatment. If the proportion of cured patients is at least 70 %, the next part, the randomized part, will be performed. In the randomized part, the treatment efficacy and safety of VagiVitalAC on candida vulvovaginitis will be evaluated by comparing a treatment group with a control group receiving no treatment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05012852
Study type	Interventional
Source	PepTonic Medical AB
Contact	Dan Markusson
Phone	+46104750800
Email	registrator@etikprovning.se
Status	Recruiting
Phase	N/A
Start date	September 2021
Completion date	June 2022

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