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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bacterial Vaginosis (BV)

Intervention / Treatment
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* Drug: LUXSOL copper containing cream
* Drug: Metronidazole gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject agrees to participate and signs informed consent Female age 18 or older Subject has clinical BV with 4 of 4 Amsel's criteria Off-white (milky or gray), thin, adherent, homogenous discharge with minimal or absent pruritus and inflammation of the vulva and vagina Presence of 'clue cells' >/=20% of the total epithelial cells on microscopic examination of the saline 'wet mount.' Virginal secretion pH of >4.5 A fishy odor of the vaginal discharge with the addition of a drop of 10% KOH (i.e. a positive 'whiff test') Subject agrees to refrain from use of douches, intravaginal products for treatment period Subject agrees to refrain from taking oral or intravaginal antibiotics or antifungal agents during entire study period Subject agrees to refrain from vaginal intercourse during treatment period. Exclusion Criteria: Subject has another infectious or noninfectious cause of vulvovaginitis Subject has another vaginal or vulvar condition that would confound the determination of study endpoints. Subject has received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days prior to enrollment. Subject is under treatment for cervical intra-epithelial neoplasia or cervical carcinoma Subject is known to be HIV positive Subject has a positive pregnancy test Subject has any abnormal anatomy or pathology of the vagina Subject has untreated sexually transmitted disease Subject is currently having menstrual period or may have her period during treatment days. Subject's PAP smear >/= to LSIL Subjects with known sensitivity or allergic reactions to copper or Metronidazole vaginal gel Subject has known Wilson's disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LUXSOL Cream<br>LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights. | Drug: LUXSOL copper containing cream<br>* Active comparator arm<br>* Other names: LUXSOL Topical Cream;|
| Active Comparator: Metronidazole cream<br>Metronidazole cream is the active comparator drug to be self-administered intravaginally each night before bedtime for 10 consecutive nights. Dosage is per package insert. | Drug: Metronidazole gel<br>* Active comparator for treatment of bacterial vaginosis<br>* Other names: Metrogel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of bacterial vaginosis at the end of the study | Patients will be assessed at day 30 for the presence or absence of bacterial Vaginosis (BV). Absence of BV will be considered a cure. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial Vaginosis (BV), Amsel's criteria, Pap smear