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

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Female

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..

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CDA Research Group, Inc.
• Treatments: Copper; Metronidazole

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