Bacterial Vaginosis (BV) Clinical Trial
Official title:
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
| Verified date | March 2015 |
| Source | CDA Research Group, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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..
| Status | Terminated |
| Enrollment | 50 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Harper University Hospital Department of Infectious Diseases | Detroit | Michigan |
| United States | Temple University Hospital Department of OB/GYN | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| CDA Research Group, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |