Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis

Phase 4

Not yet recruiting

• Conditions: Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina
• Interventions: Other: L-Mesitran; Drug: Fluconazole

• Registration Number: NCT04626258
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-11-10
• Last Update Submitted: 2020-11-10
• Study First Posted: 2020-11-12
• Last Update Posted: 2020-11-12
• Study Start: 2021-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Mesitran	L-Mesitran	The first month every day apply L-mesitran, the next five months apply L-mesitran every week on the vagina
Active comparator: Fluconazol	Fluconazole	Once a month one capsule Fluconazol 150 mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.