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

NCT02860845 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-11-19

Study results available
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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).

Conditions

  • Candidiasis
  • Vaginosis, Bacterial

Interventions

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.

Sponsors & Collaborators

  • Clever Instruments S.L.

    collaborator INDUSTRY

  • Laboratorios Ordesa

    lead INDUSTRY

Principal Investigators

  • Juan A Tena, Dr. · Ginemed Sevilla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-12
Primary Completion
2017-10-16
Completion
2017-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02860845 on ClinicalTrials.gov