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

Sponsor
Karo Pharma AB (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05552378
Collaborator
(none)
40
Enrollment
1
Arm
1
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Multi-Gyn FloraFem
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Arm Stuidy to Confirm Safety and Efficacy of Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Single arm

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

Outcome Measures

Primary Outcome Measures

  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. [1 week]

    Women should have at least itch related to vaginal candidiasis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Karo Pharma AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karo Pharma AB
ClinicalTrials.gov Identifier:
NCT05552378
Other Study ID Numbers:
  • 22E2054
First Posted:
Sep 23, 2022
Last Update Posted:
Jan 25, 2023
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal

Study Results

No Results Posted as of Jan 25, 2023