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

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05552378
• Other study ID #: 22E2054
• Status: Completed
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: April 5, 2023

Study information

• Verified date: September 2022
• Source: Karo Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 5, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Device:
• Multi-Gyn FloraFem
Vaginal gel packed in 5 single use plastic tubes.

Locations

Country	Name	City	State
Poland	General Medical Centre	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Karo Pharma AB

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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