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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05552378

Enrollment

Registered

2022-09-23

Start date

2023-02-20

Completion date

2023-04-05

Last updated

2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvovaginal Candidiasis

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.

Interventions

DEVICEMulti-Gyn FloraFem

Vaginal gel packed in 5 single use plastic tubes.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026