Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis

• ClinicalTrials.gov Identifier: NCT04626258
• Recruitment Status: Not yet recruiting
• First Posted: November 12, 2020
• Last Update Posted: November 12, 2020
• Sponsor: Maastricht University Medical Center
• Information provided by (Responsible Party): Maastricht University Medical Center

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
Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina	Drug: Fluconazole; Other: L-Mesitran	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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
• Estimated Study Start Date: March 1, 2021
• Estimated Primary Completion Date: March 1, 2024
• Estimated Study Completion Date: March 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 Name: 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 Name: Medical honey

Outcome Measures

Primary Outcome Measures :

1. Vaginal swab [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

No Contacts or Locations Provided

More Information

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT04626258
• Other Study ID Numbers: NL 73794.068.20
• First Posted: November 12, 2020
• Last Update Posted: November 12, 2020
• Last Verified: October 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:

Treatment; L-Mesitran; Fluconazol; Vaginal swabs

Additional relevant MeSH terms:

Candidiasis; Candidiasis, Vulvovaginal; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Vulvitis; Vulvar Diseases; Fluconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors