The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms

NCT ID: NCT05367089

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2027-04-22

Brief Summary

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.

Detailed Description

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.

Conditions

Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluconazole

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.

Group Type: ACTIVE_COMPARATOR

Fluconazole

Intervention Type: DRUG

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.

L-Mesitran

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.

Group Type: EXPERIMENTAL

L-Mesitran

Intervention Type: DEVICE

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.

Interventions

Fluconazole

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.

Intervention Type: DRUG

L-Mesitran

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.

Intervention Type: DEVICE

Other Intervention Names

diflucan

Eligibility 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 or contra-indications for Fluconazole or honey
• Candida with resistance for Fluconazole
• Women giving breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zuyderland Medical Centre

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zuyderland Medical Centre

Heerlen, , Netherlands

Site Status: RECRUITING

MaastrichtUMC

Maastricht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Senna van Riel, MD

Role: primary

honing@zuyderland.nl

+31884599702

Celine Lardenoije, MD

Role: primary

honing.gyn@mumc.nl

+31433874800

References

van Riel SJJM, Lardenoije CMJG, Wassen MMLH, van Kuijk SMJ, Cremers NAJ. Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY). BMJ Open. 2023 Aug 28;13(8):e070466. doi: 10.1136/bmjopen-2022-070466.

Reference Type: DERIVED

PMID: 37640455 (View on PubMed)

Other Identifiers

NL73974.068.21

Identifier Type: -

Identifier Source: org_study_id