Back to resultsMulti-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms
Primary Purpose
Vulvovaginal Candidiasis
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Multi-Gyn FloraFem
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Candidiasis
Eligibility Criteria
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
Sites / Locations
- General Medical Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05552378
Brief Title
Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms
Official Title
A Single Arm Stuidy to Confirm Safety and Efficacy of Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
April 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karo Pharma AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Multi-Gyn FloraFem
Intervention Description
Vaginal gel packed in 5 single use plastic tubes.
Primary Outcome Measure Information:
Title
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.
Description
Women should have at least itch related to vaginal candidiasis.
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
General Medical Centre
City
Gdańsk
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms
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