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Effect of Ultra-gyn® on Vulvovaginal Candidiasis

Primary Purpose

Vulvovaginal Candidiasis, Genital

Status
Recruiting
Phase
Not Applicable
Locations
Mauritius
Study Type
Interventional
Intervention
Ultra-gyn®
Sponsored by
Biocodex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vulvovaginal Candidiasis, Genital

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • IRRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ultra-gyn®

Arm Description

ovule

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

To assess the effect of Ultra-gyn® on Candida spp
Change in vaginal load of Candida spp (CFU Enumeration)
To assess the effect of Ultra-gyn® on vaginal microbiota
Analysis with shotgun metagenomic sequencing of change in taxonomic composition of the vaginal microbiota
To assess the incidence of adverse effects
Number, nature and characteristics of any adverse reactions
To assess the incidence of device deficiencies
Number, nature and characteristics of any device deficiencies

Full Information

First Posted
February 9, 2022
Last Updated
March 9, 2022
Sponsor
Biocodex
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1. Study Identification

Unique Protocol Identification Number
NCT05273333
Brief Title
Effect of Ultra-gyn® on Vulvovaginal Candidiasis
Official Title
Effect of Ultra-gyn® on Vulvovaginal Candidiasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocodex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis, Genital

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A Prospective, Single-center, Open-label, Post-market Clinical Follow-up Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultra-gyn®
Arm Type
Other
Arm Description
ovule
Intervention Type
Device
Intervention Name(s)
Ultra-gyn®
Intervention Description
Ultra-gyn® ovule intravaginal application, every evening before bedtime for a 10 days period.
Primary Outcome Measure Information:
Title
To assess the effect of Ultra-gyn® in relieving the symptoms of Vulvovaginal Candidiasis
Description
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)
Time Frame
Day 0 to Day 30 (+/-5)
Secondary Outcome Measure Information:
Title
To assess the effect of Ultra-gyn® on Candida spp
Description
Change in vaginal load of Candida spp (CFU Enumeration)
Time Frame
Day 0 and Day 30 (+/-5)
Title
To assess the effect of Ultra-gyn® on vaginal microbiota
Description
Analysis with shotgun metagenomic sequencing of change in taxonomic composition of the vaginal microbiota
Time Frame
Day 0 and Day 30 (+/-5)
Title
To assess the incidence of adverse effects
Description
Number, nature and characteristics of any adverse reactions
Time Frame
Day 1 to Day 30 (+/-5)
Title
To assess the incidence of device deficiencies
Description
Number, nature and characteristics of any device deficiencies
Time Frame
Day 1 to Day 30 (+/-5)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, 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: 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 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, Is not willing to stop taking probiotics dietary supplements and food products enriched with probiotics, Is planning to change her usual habits (hygiene, dietary habits, tobacco and alcohol consumption, physical activity and sexual life) during the study, Has participated in an interventional clinical study in the month prior to inclusion.
Facility Information:
Facility Name
IR
City
Quatre Bornes
ZIP/Postal Code
60200
Country
Mauritius
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Managing Director
Phone
467 0231
Email
contact@insight-research.com
First Name & Middle Initial & Last Name & Degree
Farah BOLAKY, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Ultra-gyn® on Vulvovaginal Candidiasis

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