NCT02197182

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

An Open-Label, Randomized Study to Determine the Safety and Efficacy of LUXSOL(TM) Cream for the Treatment of Bacterial Vaginosis: A Proof of Concept Study

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: CDA Research Group, Inc. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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..

Detailed description

LUXSOL Topical Cream is a copper containing topical cream indicated for the treatment of bacterial vaginosis (BV). The study is an open-label, randomized, controlled study comparing LUXSOL Cream to Metrogel in patients with a diagnosis of BV. The investigational product or the comparator product will be self-administered by the patient for 10 consecutive nights. A successful patient outcome is cured BV at 30 days.

Conditions

• Bacterial Vaginosis (BV)

Interventions

Type	Name	Description
DRUG	LUXSOL copper containing cream	Active comparator arm
DRUG	Metronidazole gel	Active comparator for treatment of bacterial vaginosis

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-07-22
• Last updated: 2018-04-05

Locations

2 sites across 1 country: United States