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LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study

NCT02197182 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-04-05

No results posted yet for this study

Summary

LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..

Conditions

  • Bacterial Vaginosis (BV)

Interventions

DRUG

LUXSOL copper containing cream

Active comparator arm

DRUG

Metronidazole gel

Active comparator for treatment of bacterial vaginosis

Sponsors & Collaborators

  • CDA Research Group, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

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 NCT02197182 on ClinicalTrials.gov