NCT Number: NCT05367089
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 3
Zuyderland Medical Centre, Heerlen, Netherlands
The purpose of this study is to investigate the vaginal culture (positive or negative) after the application of a Medical Grade Honey formulation (L-Mesitran ®) in relation to the current standard of care (Fluconazole) 1 month after starting treatment in patients with RVCC. As a secondary outcome, the effects on symptoms, including redness, irritation, itching, dysuria, dyspareunia and vaginal discharge will be analyzed. In addition, the vaginal culture after 6 months maintenance application and the number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, and quality of life will be collected and compared. The study ends after 252 included patients completed the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: diflucan
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.
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. The vaginal swab will be analyzed in the laboratory to determine the presence or absence of microorganisms and thus the mycological cure rate.
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. 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).
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. 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).
Time frame: 1 month
The secondary objectives are to investigate the effects of both treatments on the 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 treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Time frame: 6 months
The secondary objectives are to investigate the effects of both treatments on the 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 treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Time frame: 9 months
The secondary objectives are to investigate the effects of both treatments on the 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 treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Time frame: 12 months
The secondary objectives are to investigate the effects of both treatments on the 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 treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.
Time frame: 1 month
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Time frame: 6 months
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Time frame: 9 months
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Time frame: 12 months
Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Maastricht University Medical Center
Other
A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06572488
Bacterial Infections and Mycoses, Candidiasis
Mendoza, Argentina
View Trial DetailsNCT07521137
Bacterial Infections and Mycoses, Candidiasis
Birmingham, Alabama, United States
View Trial DetailsNCT04930107
Bacterial Infections and Mycoses, Candidiasis
Winnipeg, Manitoba, Canada
View Trial DetailsNCT02733432
Bacterial Infections and Mycoses, Candidiasis
Birmingham, Alabama, United States
View Trial Details