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Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis

NCT05012852 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2021-09-23

No results posted yet for this study

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.

Conditions

  • Vaginal Candidiasis
  • Vulvovaginal Candidiasis
  • Candidal Vulvovaginitis

Interventions

DEVICE

VagiVitalAC

In the Pilot part, the single intervention used is VagiVitalAC treatment for 30 days. In the randomized part, patients in the Interventional arm are treated with VagiVital AC for up to 90 days.

Sponsors & Collaborators

  • StatCons

    collaborator UNKNOWN

  • Karolinska Trial Alliance

    collaborator INDUSTRY

  • PepTonic Medical AB

    lead INDUSTRY

Principal Investigators

  • Aino Fianu Jonasson, MD, PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-02-28
Completion
2022-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05012852 on ClinicalTrials.gov