Effect of Ultra-gyn® on Vulvovaginal Candidiasis

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)

Study Overview

• Status: Recruiting
• Conditions: Vulvovaginal Candidiasis, Genital
• Intervention / Treatment: Device: Ultra-gyn®

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mauritius
  • Quatre Bornes, Mauritius, 60200
    • Recruiting
    • IR
    • Contact: Managing Director; Phone Number: 467 0231; Email: contact@insight-research.com
    • Principal Investigator: Farah BOLAKY, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

To be eligible, each patient must satisfy the following criteria:

1. Is a non-menopausal woman aged 18 to 45 years,
2. Suffering from a vulvovaginal candidiasis (according to clinical examination),
3. Who was being prescribed standard antifungal therapy for Vulvovaginal Candidiasis,
4. Has regular menstrual cycles (21-35 days) or no menstruation due to continuous use of contraception,
5. Is able to understand the study related information and to give a written informed consent,
6. Has signed the informed consent form before beginning any study procedure,
7. Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
8. Agrees not to use a diaphragm, spermicide or latex condoms, contraceptive creams and spermicide ovules during participation in the study,
9. 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,
10. Has no condition that may interfere with the study assessments
11. Is affiliated to a health social security system,
12. Is able to comply with protocol requirements and respect the conditions of the study,

Exclusion Criteria:

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:

1. Has had a sexually transmitted disease in the 21 days preceding screening or detected on this occasion,
2. Has a history of recurrent fungaemia,
3. 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),
4. Has had pelvic surgery in the 3 months prior to screening,
5. Has had uterine or vaginal bleeding of unknown etiology,
6. Immunocompromised,
7. Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments,
8. Is pregnant (positive pregnancy test at screening), has given birth less than 2 months ago or is breastfeeding,

9. Has changed her method of contraception in the 2 months prior to screening,

   Criteria related to contraindications to the product used within the study:

10. With a known allergy or presenting an hypersensitivity to one of the component of the study product,

11. 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

12. Has taken systemic or intravaginal antibiotic or antifungal agents (other than those prescribed during the inclusion visit) in the 14 days preceding the screening visit,
13. Is not willing to stop taking probiotics dietary supplements and food products enriched with probiotics,
14. Is planning to change her usual habits (hygiene, dietary habits, tobacco and alcohol consumption, physical activity and sexual life) during the study,
15. Has participated in an interventional clinical study in the month prior to inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ultra-gyn®; ovule	Device: Ultra-gyn®; Ultra-gyn® ovule intravaginal application, every evening before bedtime for a 10 days period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effect of Ultra-gyn® on Candida spp	Change in vaginal load of Candida spp (CFU Enumeration)	Day 0 and Day 30 (+/-5)
To assess the effect of Ultra-gyn® on vaginal microbiota	Analysis with shotgun metagenomic sequencing of change in taxonomic composition of the vaginal microbiota	Day 0 and Day 30 (+/-5)
To assess the incidence of adverse effects	Number, nature and characteristics of any adverse reactions	Day 1 to Day 30 (+/-5)
To assess the incidence of device deficiencies	Number, nature and characteristics of any device deficiencies	Day 1 to Day 30 (+/-5)

Collaborators and Investigators

• Sponsor: Biocodex

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal
• Other Study ID Numbers: SbO216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No