NCT05367089

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P50-P75 for phase_3

Timeline
12mo left

Started Aug 2022

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Aug 2022Apr 2027

First Submitted

Initial submission to the registry

April 28, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2027

Expected
Last Updated

May 17, 2023

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

April 28, 2022

Last Update Submit

May 15, 2023

Conditions

Candidiasis, VulvovaginalRecurrent Candidiasis of Vagina

Keywords

L-MesitranFluconazolvaginal swabsmedical grade honeyantifungal activity

Outcome Measures

Primary Outcomes (3)

  • 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.

    1 month

  • 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).

    6 months

  • 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).

    12 months

Secondary Outcomes (8)

  • Quality of life will be determined with questionnaires

    1 month

  • Quality of life will be determined with questionnaires

    6 months

  • Quality of life will be determined with questionnaires

    9 months

  • Quality of life will be determined with questionnaires

    12 months

  • Side effects of medication will be determined with questionnaires

    1 month

  • +3 more secondary outcomes

Study Arms (2)

Fluconazole

ACTIVE COMPARATOR

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.

Drug: Fluconazole

L-Mesitran

EXPERIMENTAL

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.

Device: L-Mesitran

Interventions

FluconazoleDRUG

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.

Also known as: diflucan
Fluconazole
L-MesitranDEVICE

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.

L-Mesitran

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Mixed vaginal infections
  • Pregnancy or the intention to become pregnant during the study period
  • Known allergies or contra-indications for Fluconazole or honey
  • Candida with resistance for Fluconazole
  • Women giving breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zuyderland Medical Centre

Heerlen, Netherlands

RECRUITING

MaastrichtUMC

Maastricht, Netherlands

RECRUITING

Related Publications (1)

  • van Riel SJJM, Lardenoije CMJG, Wassen MMLH, van Kuijk SMJ, Cremers NAJ. Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY). BMJ Open. 2023 Aug 28;13(8):e070466. doi: 10.1136/bmjopen-2022-070466.

    PMID: 37640455DERIVED

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 10, 2022

Study Start

August 22, 2022

Primary Completion

April 22, 2026

Study Completion (Estimated)

April 22, 2027

Last Updated

May 17, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

NL(2)