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Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis

NCT ID: NCT04626258

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Candidiasis, Vulvovaginal Recurrent Candidiasis of Vagina

Keywords

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Treatment L-Mesitran Fluconazol Vaginal swabs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active comparator: Fluconazol

Once a month one capsule Fluconazol 150 mg

Group Type ACTIVE_COMPARATOR

Fluconazole

Intervention Type DRUG

Fluconazol once a month 150 mg capsule

L-Mesitran

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

Group Type EXPERIMENTAL

L-Mesitran

Intervention Type OTHER

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

Interventions

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Fluconazole

Fluconazol once a month 150 mg capsule

Intervention Type DRUG

L-Mesitran

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

Intervention Type OTHER

Other Intervention Names

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Diflucan Medical honey

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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NL 73794.068.20

Identifier Type: -

Identifier Source: org_study_id