Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections

• Status: Completed
• Trial end date: 2017-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference controls (depending on the suspected diagnosis).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Ordesa
• Collaborator: Clever Instruments S.L.
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Antifungal Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Clotrimazole; Miconazole; Tetrahydrozoline

Criteria

Inclusion Criteria:

• Age over 18 years and agreement to participate by signing the consent form.

• Women with clinical manifestations of acute infectious vulvovaginitis (burning, pruritus, erythema, oedema, and abnormal vaginal discharge).

Exclusion Criteria:

• Clinical findings compatible with Chlamydia trachomatis, Neisseria gonorrhoeae or Trichomonas vaginalis infection.

• Use of anti-fungal, antibiotic or probiotic medication within last 2 weeks prior to the study.

• Patients receiving other treatment (drug, probiotics or vitamin supplements) that can significantly interfere with study evaluations during the 3 months of follow-up.

• Pregnant or high risk for pregnancy.