Last reviewed · How we verify
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
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..
Details
| Lead sponsor | CDA Research Group, Inc. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | TERMINATED |
| Enrolment | 50 |
| Start date | 2014-06 |
| Completion | 2015-03 |
Conditions
- Bacterial Vaginosis (BV)
Interventions
- LUXSOL copper containing cream
- Metronidazole gel
Primary outcomes
- Presence or absence of bacterial vaginosis at the end of the study — 30 days
Patients will be assessed at day 30 for the presence or absence of bacterial Vaginosis (BV). Absence of BV will be considered a cure.
Countries
United States