CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
Antibiotic (Clindamycin) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02860845
NCT02860845Phase 4Completed

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

Laboratorios Ordesa·interventional·Posted Aug 9, 2016·Updated Nov 19, 2019

In Brief

A Phase 4 clinical trial evaluating Boric acid and probiotics, Antibiotic (Clindamycin), and 1 other intervention for Candidiasis and Vaginosis, Bacterial. Completed, enrolled 48 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 9, 2016
Enrollment StartJul 12, 2016
Primary CompletionOct 16, 2017
Study CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.9 years ago

Interventions

Boric acid and probioticsdevice

Vaginal capsules administered once a day during 7 days.

Antibiotic (Clindamycin)drug

Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.

Antifungal (Clotrimazole)drug

Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.