LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
Information source: CDA Research Group, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Vaginosis (BV)
Intervention: LUXSOL copper containing cream (Drug); Metronidazole gel (Drug)
Phase: Phase 0
Status: Suspended
Sponsored by: CDA Research Group, Inc.
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..
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Presence or absence of bacterial vaginosis at the end of the study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Harper University Hospital Department of Infectious Diseases, Detroit, Michigan 48201, United States
Temple University Hospital Department of OB/GYN, Philadelphia, Pennsylvania 19140, United States
Additional Information
Starting date: June 2014
Last updated: March 20, 2015
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