Effect of Ultra-gyn® on Vulvovaginal Candidiasis

NCT05273333 | Unknown DMC

• 1 other identifier: SbO216
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this post-market clinical follow up study is to confirm the performance and the safety of Ultra-gyn® (when used in accordance with its approved labelling)

Conditions

Vulvovaginal Candidiasis, Genital

Outcome Measures

Primary Outcomes (1)

• To assess the effect of Ultra-gyn® in relieving the symptoms of Vulvovaginal Candidiasis

  Change in vulvovaginal symptoms (5-point rating scale (ranging from 0 to 4, where 0=None and 4=Very severe) for vaginal itching, vaginal burning or soreness and vaginal discharge)

  Day 0 to Day 30 (+/-5)

Secondary Outcomes (4)

• To assess the effect of Ultra-gyn® on Candida spp

  Day 0 and Day 30 (+/-5)

• To assess the effect of Ultra-gyn® on vaginal microbiota

  Day 0 and Day 30 (+/-5)

• To assess the incidence of adverse effects

  Day 1 to Day 30 (+/-5)

• To assess the incidence of device deficiencies

  Day 1 to Day 30 (+/-5)

Study Arms (1)

Ultra-gyn®

OTHER

ovule

Device: Ultra-gyn®

Interventions

Ultra-gyn® DEVICE

Ultra-gyn® ovule intravaginal application, every evening before bedtime for a 10 days period.

Ultra-gyn®

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be eligible, each patient must satisfy the following criteria:
• Is a non-menopausal woman aged 18 to 45 years,
• Suffering from a vulvovaginal candidiasis (according to clinical examination),
• Who was being prescribed standard antifungal therapy for Vulvovaginal Candidiasis,
• Has regular menstrual cycles (21-35 days) or no menstruation due to continuous use of contraception,
• Is able to understand the study related information and to give a written informed consent,
• Has signed the informed consent form before beginning any study procedure,
• Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
• Agrees not to use a diaphragm, spermicide or latex condoms, contraceptive creams and spermicide ovules during participation in the study,
• Uses an effective method of contraception (contraceptive steroid \[oral, patch, injection, implant\], intrauterine device, vasectomized partner, history of permanent sterilization such as tubal ligation, hysterectomy, etc.) or abstinence,
• Has no condition that may interfere with the study assessments
• Is affiliated to a health social security system,
• Is able to comply with protocol requirements and respect the conditions of the study,

You may not qualify if:

• Patients meeting at least one of the following criteria cannot be included in the study:
• Criteria related to a medical condition that would compromise patient safety or data fidelity:
• Has had a sexually transmitted disease in the 21 days preceding screening or detected on this occasion,
• Has a history of recurrent fungaemia,
• Has a history of recurrent vulvovaginal candidiasis (defined as more than four episodes of vulvovaginal candidiasis in the previous year or two episodes in the last six months),
• Has had pelvic surgery in the 3 months prior to screening,
• Has had uterine or vaginal bleeding of unknown etiology,
• Immunocompromised,
• Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments,
• Is pregnant (positive pregnancy test at screening), has given birth less than 2 months ago or is breastfeeding,
• Has changed her method of contraception in the 2 months prior to screening,
• Criteria related to contraindications to the product used within the study:
• With a known allergy or presenting an hypersensitivity to one of the component of the study product,
• Presenting a contraindication or special warning to the study product, according to the package leaflet, including concomitant use of antifungal therapy during Ultra-gyn application,
• Criteria related to medications or situations that would interfere with or compromise data fidelity

Sponsors & Collaborators

• Biocodex: lead

Study Sites (1)

IR

Quatre Bornes, 60200, Mauritius

RECRUITING

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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Prospective, Single-center, Open-label, Post-market Clinical Follow-up Study

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 10, 2022
• Study Start: February 23, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)