NCT02860845

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

Multicenter Pilot Study to Compare the Efficacy of a Combination of Vaginal Capsules With Acid Boric, L.Gasseri and L.Rhamnosus Versus the Reference Medication in Patients With Vaginal Candidiasis or Bacterial Vaginosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Laboratorios Ordesa · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Multicentre, Open, Prospective, Randomized, Controlled. Women with suspected vaginal infection will be randomized and distributed into two groups (control or boric acid + probiotics). Follow-up will last for three months and consists in 3 visits and a telephone interview.

Conditions

• Candidiasis
• Vaginosis, Bacterial

Interventions

Type	Name	Description
DEVICE	Boric acid and probiotics	Vaginal capsules administered once a day during 7 days.
DRUG	Antibiotic (Clindamycin)	Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
DRUG	Antifungal (Clotrimazole)	Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.

Timeline

• Start date: 2016-07-12
• Primary completion: 2017-10-16
• Completion: 2017-11-30
• First posted: 2016-08-09
• Last updated: 2019-11-19
• Results posted: 2019-11-04

Locations

1 site across 1 country: Spain