Back to resultsThe Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms
Primary Purpose
Candidiasis, Vulvovaginal, Recurrent Candidiasis of Vagina
Status
Recruiting
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Fluconazole
L-Mesitran
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis, Vulvovaginal focused on measuring L-Mesitran, Fluconazol, vaginal swabs, medical grade honey, antifungal activity
Eligibility Criteria
Inclusion Criteria:
- Women of at least 18 years old
- Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
- Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
- Capacity to understand, consent, and comply with the trial procedures
Exclusion Criteria:
- Mixed vaginal infections
- Pregnancy or the intention to become pregnant during the study period
- Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
- Known allergies or contra-indications for Fluconazole or honey
- Candida with resistance for Fluconazole
- Women giving breastfeeding
Sites / Locations
- Zuyderland Medical CentreRecruiting
- MaastrichtUMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fluconazole
L-Mesitran
Arm Description
Way of administration: oral capsules. One capsule at the same day of the week. Dosage: As treatment for active RVVC- in the first week on day 1 one capsule 150 mg Fluconazole, on day 4 one capsule 150 mg Fluconazole and on day 7 one capsule 150 mg Fluconazole. As prophylaxis to prevent a new RVVC episode: one capsule Fluconazol 150 mg per week for a duration of 6 months.
Way of administration: intra-vaginal application using an applicator. Dosage: As treatment for active RVVC - Single daily application (5 grams) for 1 month. As prophylaxis to prevent a new RVVC episode: Single weekly (5 grams) application for 5 months.
Outcomes
Primary Outcome Measures
vaginal swab
The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. The vaginal swab will be analyzed in the laboratory to determine the presence or absence of microorganisms and thus the mycological cure rate.
vaginal swab
The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).
vaginal swab
The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).
Secondary Outcome Measures
Quality of life will be determined with questionnaires
The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Quality of life will be determined with questionnaires
The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Quality of life will be determined with questionnaires
The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Quality of life will be determined with questionnaires
The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Side effects of medication will be determined with questionnaires
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Side effects of medication will be determined with questionnaires
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Side effects of medication will be determined with questionnaires
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Side effects of medication will be determined with questionnaires
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Full Information
NCT ID
NCT05367089
First Posted
April 28, 2022
Last Updated
May 15, 2023
Sponsor
Maastricht University Medical Center
Collaborators
Zuyderland Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT05367089
Brief Title
The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms
Official Title
A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
April 22, 2026 (Anticipated)
Study Completion Date
April 22, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Zuyderland Medical Centre
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 the study is to investigate the efficacy of Fluconazol versus L-Mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. Vaginal swabs will be analyzed after 1, 6 and 12 months. The study ends after 252 included patients completed the study.
Detailed Description
The purpose of this study is to investigate the vaginal culture (positive or negative) after the application of a Medical Grade Honey formulation (L-Mesitran ®) in relation to the current standard of care (Fluconazole) 1 month after starting treatment in patients with RVCC. As a secondary outcome, the effects on symptoms, including redness, irritation, itching, dysuria, dyspareunia and vaginal discharge will be analyzed. In addition, the vaginal culture after 6 months maintenance application and the number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, and quality of life will be collected and compared. The study ends after 252 included patients completed the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Vulvovaginal, Recurrent Candidiasis of Vagina
Keywords
L-Mesitran, Fluconazol, vaginal swabs, medical grade honey, antifungal activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluconazole
Arm Type
Active Comparator
Arm Description
Way of administration: oral capsules. One capsule at the same day of the week.
Dosage:
As treatment for active RVVC- in the first week on day 1 one capsule 150 mg Fluconazole, on day 4 one capsule 150 mg Fluconazole and on day 7 one capsule 150 mg Fluconazole.
As prophylaxis to prevent a new RVVC episode: one capsule Fluconazol 150 mg per week for a duration of 6 months.
Arm Title
L-Mesitran
Arm Type
Experimental
Arm Description
Way of administration: intra-vaginal application using an applicator.
Dosage:
As treatment for active RVVC - Single daily application (5 grams) for 1 month. As prophylaxis to prevent a new RVVC episode: Single weekly (5 grams) application for 5 months.
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
diflucan
Intervention Description
Way of administration: oral capsules. One capsule at the same day of the week.
Dosage:
As treatment for active RVVC- in the first week on day 1 one capsule 150 mg Fluconazole, on day 4 one capsule 150 mg Fluconazole and on day 7 one capsule 150 mg Fluconazole.
As prophylaxis to prevent a new RVVC episode: one capsule Fluconazol 150 mg per week for a duration of 6 months.
Intervention Type
Device
Intervention Name(s)
L-Mesitran
Intervention Description
Way of administration: intra-vaginal application using an applicator.
Dosage:
As treatment for active RVVC - Single daily application (5 grams) for 1 month. As prophylaxis to prevent a new RVVC episode: Single weekly (5 grams) application for 5 months.
Primary Outcome Measure Information:
Title
vaginal swab
Description
The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. The vaginal swab will be analyzed in the laboratory to determine the presence or absence of microorganisms and thus the mycological cure rate.
Time Frame
1 month
Title
vaginal swab
Description
The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).
Time Frame
6 months
Title
vaginal swab
Description
The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life will be determined with questionnaires
Description
The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Time Frame
1 month
Title
Quality of life will be determined with questionnaires
Description
The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Time Frame
6 months
Title
Quality of life will be determined with questionnaires
Description
The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Time Frame
9 months
Title
Quality of life will be determined with questionnaires
Description
The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Time Frame
12 months
Title
Side effects of medication will be determined with questionnaires
Description
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Time Frame
1 month
Title
Side effects of medication will be determined with questionnaires
Description
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Time Frame
6 months
Title
Side effects of medication will be determined with questionnaires
Description
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Time Frame
9 months
Title
Side effects of medication will be determined with questionnaires
Description
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women of at least 18 years old
Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
Capacity to understand, consent, and comply with the trial procedures
Exclusion Criteria:
Mixed vaginal infections
Pregnancy or the intention to become pregnant during the study period
Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
Known allergies or contra-indications for Fluconazole or honey
Candida with resistance for Fluconazole
Women giving breastfeeding
Facility Information:
Facility Name
Zuyderland Medical Centre
City
Heerlen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senna van Riel, MD
Phone
+31884599702
Email
honing@zuyderland.nl
Facility Name
MaastrichtUMC
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine Lardenoije, MD
Phone
+31433874800
Email
honing.gyn@mumc.nl
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data and conclusions that emerge from the study will be described in one or more articles in international peer-reviewed journal(s) and will follow the CCMO guidelines. In addition, the data may also be submitted for presentation at medical congresses. Data and reprints may be shared upon reasonable request. Individual participant data after deidentification may be shared with researchers who provide a methodologically sound proposal. Proposals should be addressed to the principal investigators or corresponding authors within 36 months following article publication.
Learn more about this trial
The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms
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