Bacterial Vaginosis (BV)
Conditions
Keywords
Bacterial Vaginosis (BV), Amsel's criteria, Pap smear
Brief 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.
Interventions
DRUGLUXSOL copper containing cream
Active comparator arm
Active comparator for treatment of bacterial vaginosis
Sponsors
CDA Research Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
Outcome results
None listed