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Activities of Metronidazole + Clotrimazole in the treatment and prophylaxis of recurrent vaginal infections recurrent Candida albicans and Candida albicans spp do not.

Activities of Metronidazole + Clotrimazole in the treatment and prophylaxis of recurrent vaginal infections recurrent Candida albicans and Candida albicans spp do not. - MELCOM-1

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-004718-40-IT
Enrollment
Unknown
Registered
2012-03-08
Start date
2011-07-18
Completion date
Unknown
Last updated
2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

women with vaginal infections by Candida albicans and non-albicans Candida spp relapsing recurrent (= 4 events / year) in the acute phase of the disease. MedDRA version: 14.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: MECLON*10 OVULI VAG 100+500MG Pharmaceutical Form: Pessary INN or Proposed INN: NA CAS Number: 23593-75-1 Current Sponsor code: NA Other descriptive name: CLOTRIMAZOLE METRONIDAZOLE Concen

Sponsors

AISAR ASSOCIAZIONE ITALIANA PER LO STUDIO DEGLI ANTIMICROBICI E DELLE RESISTENZE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Women will be recruited (age range 18-50) with a vaginal infection by Candida albicans and non-albicans Candida spp relapsing recurrent (= 4 events / year) in the acute phase of the disease. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Are not eligible for the study, patients who refuse consent baccalaureate study, in the case of taking birth control and pregnancy.

Design outcomes

Primary

MeasureTime frame
Main Objective: Measuring the incidence of healing and the reduction of recurrent vulvovaginal candidiasis events following treatment with the combination of Metronidazole - Clotrimazole;Secondary Objective: Define dose and timing of treatment more effective for prophylaxis with relapse;Primary end point(s): Vulvovaginal candidiasis reduction of recurrent events following treatment with the combination of Metronidazole - Clotrimazole;Timepoint(s) of evaluation of this end point: 6 months—

Secondary

MeasureTime frame
Secondary end point(s): Improving the average health of patients;Timepoint(s) of evaluation of this end point: 3 months—

Countries

Italy

Contacts

Public ContactInformazione sulla sperimentazione

AISAR

A.MAROTTA@AISAR.ORG+39 02 59902320

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026