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

NCT02197182 | Terminated Early Phase 1

• 1 other identifier: CDA 0801
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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..

Conditions

Bacterial Vaginosis (BV)

Keywords

Bacterial Vaginosis (BV); Amsel's criteria; Pap smear

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

LUXSOL Cream

EXPERIMENTAL

LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.

Drug: LUXSOL copper containing cream

Metronidazole cream

ACTIVE COMPARATOR

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

Interventions

LUXSOL copper containing cream DRUG

Active comparator arm

Also known as: LUXSOL Topical Cream

LUXSOL Cream

Metronidazole gel DRUG

Active comparator for treatment of bacterial vaginosis

Also known as: Metrogel

Metronidazole cream

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CDA Research Group, Inc.: lead

Study Sites (2)

Harper University Hospital Department of Infectious Diseases

Detroit, Michigan, 48201, United States

Location

Temple University Hospital Department of OB/GYN

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: July 22, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 5, 2018

Record last verified: 2015-03

Locations

US (2)