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

NCT05552378 | Completed

• 1 other identifier: 22E2054
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Women should have at least itch related to vaginal candidiasis.

  1 week

Study Arms (1)

Single arm

OTHER

Device: Multi-Gyn FloraFem

Interventions

Multi-Gyn FloraFem DEVICE

Vaginal gel packed in 5 single use plastic tubes.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karo Pharma AB: lead

Study Sites (1)

General Medical Centre

Gdansk, Poland

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: February 20, 2023
• Primary Completion: March 30, 2023
• Study Completion: April 5, 2023
• Last Updated: June 1, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)