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
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Presence or absence of bacterial vaginosis at the end of the study
研究概览
简要总结
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..
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
LUXSOL Cream
LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.
干预措施: LUXSOL copper containing cream (Drug)
Metronidazole cream
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.
干预措施: Metronidazole gel (Drug)
结局指标
主要结局
Presence or absence of bacterial vaginosis at the end of the study
时间窗: 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.
次要结局
未报告次要终点