NCT04626258

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
252

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_4

Status
unknown

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

First Submitted

Initial submission to the registry

October 23, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

November 12, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

October 23, 2020

Last Update Submit

November 10, 2020

Conditions

Candidiasis, VulvovaginalRecurrent Candidiasis of Vagina

Keywords

TreatmentL-MesitranFluconazolVaginal swabs

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.

    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.

    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.

    12 months

Secondary Outcomes (8)

  • Quality of life will be termined with questionnaires

    1 month

  • Quality of life will be termined with questionnaires

    6 months

  • Quality of life will be termined with questionnaires

    9 months

  • Quality of life will be termined with questionnaires

    12 months

  • Side effect of medication will be termined with questionnaires

    1 month

  • +3 more secondary outcomes

Study Arms (2)

Active comparator: Fluconazol

ACTIVE COMPARATOR

Once a month one capsule Fluconazol 150 mg

Drug: Fluconazole

L-Mesitran

EXPERIMENTAL

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

Other: L-Mesitran

Interventions

FluconazoleDRUG

Fluconazol once a month 150 mg capsule

Also known as: Diflucan
Active comparator: Fluconazol
L-MesitranOTHER

The first month apply every day one sachet, the next five months apply every week one sachet.

Also known as: Medical honey
L-Mesitran

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
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 for Fluconazole or honey
  • Candida with resistance for Fluconazole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 12, 2020

Study Start

March 1, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2025

Last Updated

November 12, 2020

Record last verified: 2020-10