Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04626258
Collaborator
(none)
252
2
48

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy of Flucanzol versus L-mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. The investigator will look at vaginal swabs after 1, 6 and 12 months. The investigator included 252 patients.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
252 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial to Compare the Efficacy of a Medical Grade Honey Formulation (L-Mesitran®) and Fluconazol (Diflucan®) for the Treatment of Recurrent Vulvovaginal Candidiasis
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active comparator: Fluconazol

Once a month one capsule Fluconazol 150 mg

Drug: Fluconazole
Fluconazol once a month 150 mg capsule
Other Names:
  • Diflucan
  • Experimental: L-Mesitran

    The first month every day apply L-mesitran, the next five months apply L-mesitran every week on the vagina

    Other: L-Mesitran
    The first month apply every day one sachet, the next five months apply every week one sachet.
    Other Names:
  • Medical honey
  • Outcome Measures

    Primary Outcome Measures

    1. Vaginal swab [1 month]

      The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran®) and control (Diflucan®) groups.

    2. Vaginal swab [6 months]

      The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran®) and control (Diflucan®) groups.

    3. Vaginal swab [12 months]

      The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran®) and control (Diflucan®) groups.

    Secondary Outcome Measures

    1. Quality of life will be termined with questionnaires [1 month]

      The secondary objectives are to investigate the effects of both treatments on the clinical cure rate and 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 therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared. They will reach from no complaints-a little bit-moderate-severe

    2. Quality of life will be termined with questionnaires [6 months]

      The secondary objectives are to investigate the effects of both treatments on the clinical cure rate and 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 therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.

    3. Quality of life will be termined with questionnaires [9 months]

      The secondary objectives are to investigate the effects of both treatments on the clinical cure rate and 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 therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.

    4. Quality of life will be termined with questionnaires [12 months]

      The secondary objectives are to investigate the effects of both treatments on the clinical cure rate and 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 therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.

    5. Side effect of medication will be termined with questionnaires [1 month]

      The secondary objectives are to investigate the effects of both treatments on the clinicalcure rate and 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 therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.

    6. Side effect of medication will be termined with questionnaires [6 months]

      The secondary objectives are to investigate the effects of both treatments on the clinicalcure rate and 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 therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.

    7. Side effect of medication will be termined with questionnaires [9 months]

      The secondary objectives are to investigate the effects of both treatments on the clinicalcure rate and 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 therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.

    8. Side effect of medication will be termined with questionnaires [12 months]

      The secondary objectives are to investigate the effects of both treatments on the clinicalcure rate and 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 therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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 for Fluconazole or honey

    • Candida with resistance for Fluconazole

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Maastricht University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT04626258
    Other Study ID Numbers:
    • NL 73794.068.20
    First Posted:
    Nov 12, 2020
    Last Update Posted:
    Nov 12, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maastricht University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 12, 2020