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

Not Applicable

Completed

• Conditions: Vulvovaginal Candidiasis
• Interventions: Device: Multi-Gyn FloraFem

• Registration Number: NCT05552378
• Lead Sponsor: Karo Pharma AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-23
• Study Start: 2023-02-20
• Primary Completion: 2023-03-30
• Study Completion: 2023-04-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Multi-Gyn FloraFem	-

Primary Outcome Measures

Name	Time	Method
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.	1 week	Women should have at least itch related to vaginal candidiasis.

Trial Locations

Locations (1)

General Medical Centre; 🇵🇱 Gdańsk, Poland