Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms

May 30, 2023 updated by: Karo Pharma AB

A Single Arm Stuidy to Confirm Safety and Efficacy of Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms

Women diagnosed with Vulvovaginal Candidiasis by the health care professional will be enrolled in the study. All participants should fulfil inclusion and exclusion criteria.

The study product will be used for 5 days, once a day. The doctor will evaluate the patients before and at the end of the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Gdańsk, Poland
        • General Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • Subject affiliated to a health social security system.
  • Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end.

Exclusion Criteria:

  • 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
  • Pregnancy or currently attempting to conceive
  • Lactation
  • Use of other treatment for vaginal conditions during the course of the clinical investigation
  • Known allergies to ingredients of the product
  • Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm
Device: Multi-Gyn FloraFem
Vaginal gel packed in 5 single use plastic tubes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the efficacy of Multi-Gyn FloraFem in relieving itch during vaginal candidiasis (based on 0-10 point scale score improvement > 1 related to vulvovaginal candidiasis at Visit 2.
Time Frame: 1 week
Women should have at least itch related to vaginal candidiasis.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karo Pharma AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

April 5, 2023

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22E2054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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