Multicenter study for comparison of the efficacy of vaginal capsules with boric acid and probiotics versus other vaginal drugs, in patients with bacterial or fungal vaginal infection.

Phase 1

• Conditions: Bacterial or candidiasic vulvovaginitis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-000371-24-ES
• Lead Sponsor: aboratorios Ordesa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-18
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women:
>18 years.

With symptoms of vulvovaginal infection.

IC delivered.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Clinical evidence of Chlamydia trachomatis, Trichomona vaginalis, Neisseria gonorrhoeae o Herpes simplex.
- Use of antifungal or probiotics during the last 2 weeks before the
study.
- Patients receiving other treatment with probiotics, vitamin complexes that could interfere significantly with the study evaluations.
- Pregnant patients.
- Patients capable of becoming pregnant.
- Patients menstruating at the time of inclusion.
- Breast-feeding.
- Immunocompromised patients.
- Patients who, based on the judgment of the investigator, is not foreseen will complete the follow.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified