A Phase 3 interventional study of Fluconazole and L-Mesitran in Candidiasis, Vulvovaginal and Recurrent Candidiasis of Vagina, sponsored by Maastricht University Medical Center. Recruiting at 2 sites in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Maastricht University Medical Center · Phase 3, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.
This study's planned enrollment of 252 is above the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.
Browse Candidiasis, Vulvovaginal studies →Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Fluconazole
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.
Device: L-Mesitran
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.
Also known as: 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.
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. 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: 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. 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: 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. 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
Quality of life will be determined with questionnaires
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
Quality of life will be determined with questionnaires
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
Quality of life will be determined with questionnaires
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: 9 months
Quality of life will be determined with questionnaires
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: 12 months
Side effects of medication will be determined with questionnaires
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: 1 month
Side effects of medication will be determined with questionnaires
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
Side effects of medication will be determined with questionnaires
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
Side effects of medication will be determined with questionnaires
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
Plan to share: Yes — The data and conclusions that emerge from the study will be described in one or more articles in international peer-reviewed journal(s) and will follow the CCMO guidelines. In addition, the data may also be submitted for presentation at medical congresses. Data and reprints may be shared upon reasonable request. Individual participant data after deidentification may be shared with researchers who provide a methodologically sound proposal. Proposals should be addressed to the principal investigators or corresponding authors within 36 months following article publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Apr 2026, 44 months after the start.
Of 15 phase 3 interventional studies under Candidiasis, Vulvovaginal, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 25. This study's planned 44 months is above that.
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