Completed

Multi-Gyn FloraFem Study for Vulvo Vaginal Candidiasis Symptoms

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What is being tested

Multi-Gyn FloraFem

Device
Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Bacterial Infections and Mycoses

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2023
See protocol details

Summary

Principal SponsorKaro Pharma AB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 20, 2023

Actual date on which the first participant was enrolled.

This study focuses on treating Vulvovaginal Candidiasis, a common type of yeast infection, in women. It aims to confirm the safety and effectiveness of a treatment called Multi-Gyn FloraFem. Women diagnosed with this condition by a healthcare professional and who meet specific inclusion criteria are eligible to participate. The goal is to provide relief from symptoms and improve the current treatment options available for Vulvovaginal Candidiasis. Participants in the study will use Multi-Gyn FloraFem once a day for 5 days. The doctor will assess the patients before and after the treatment period. The main goal is to measure how well the treatment relieves itching, a common symptom of Vulvovaginal Candidiasis. This will be evaluated based on a 0-10 point scale, with improvement considered significant if the score decreases by more than 1 point at the end of the treatment.

Official TitleA Single Arm Stuidy to Confirm Safety and Efficacy of Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms
NCT05552378
Principal SponsorKaro Pharma AB
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBacterial Infections and MycosesCandidiasisCandidiasis, VulvovaginalFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleInfectionsMycosesVaginal DiseasesVaginitisVulvar DiseasesVulvitisVulvovaginitisFemale Urogenital Diseases

Criteria

6 inclusion criteria required to participate
Women diagnosed with Vulvovaginal Candidiasis confirmed by:itching, and/or burning, irritation, edema, redness, crumbly white discharge
Aged >18 years
Signed written informed consent form
Willing to comply to the follow-up schedule
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9 exclusion criteria prevent from participating
Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, bacterial vaginosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
Current genital malignancies
Chemotherapy for any reason in last 6 months
Radiotherapy in the genitourinary system in the last 12 months
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

General Medical Centre

Gdansk, PolandOpen General Medical Centre in Google Maps
CompletedOne Study Center