Efficacy, Tolerability and Safety of a New Medical Device, Zp-025 Vaginal Gel, in the Treatment of Vaginal Dryness in Post-menopausal Women With Vaginal Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Zambon SpA
- 入组人数
- 121
- 试验地点
- 6
- 主要终点
- Change in subjective symptoms of total score related to vaginal discomfort
研究概览
简要总结
Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up only for women applying ZP-025 vaginal gel.
详细描述
Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days.
This trial will be conducted in compliance with last version of Declaration of Helsinki, with GCP as applicable to investigations with IMD, with the applicable regulatory requirements and with CRO and Sponsor's SOPs.
This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study The study will take place in 6 centers of menopause at public Hospitals/Universities. An ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up visit at 4 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •caucasian women <70 years, in physiological postmenopausal status for at least 2 years;
- •women with signs and symptoms of vaginal atrophy (i. e. vaginal discomfort, itching, dyspareunia, dryness);
- •signed informed consent; willing and able to comply with study procedures
排除标准
- •childbearing potential women;
- •ascertained or presumptive hypersensitivity to the formulation ingredients;
- •therapy with systemic or vaginal oestrogens within 6 months from the inclusion;
- •current urinary or vaginal infection (cultural positive result to vaginal or urines microbiological swab in the 7 days preceding inclusion);
- •previous episodes of vaginal bleeding or spotting in the last 6 months;
- •vaginal prolapse and any other disease that could interfere with the study conduction and participation
结局指标
主要结局
Change in subjective symptoms of total score related to vaginal discomfort
时间窗: 56 days
Change in subjective symptoms of total score related to vaginal discomfort (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, and dyspareunia and vaginal bleeding associated with sexual activity) has been recorded on daily diary by subject from baseline to day 56, evaluated using a subjective evaluation scale (VRS at four items: 0= absent, 1= mild, 2=moderate, 3=severe). Each item is summed up to get to a total symptoms score.
次要结局
- change of vaginal health index(56 days)
- change of maturation index(56 days)
- change of Female Sexual Function Index(56 days)
- change of cariopicnotic index (CPI),(56 days)
- change in each subjective symptom score related to vaginal discomfort(56 days)
- local tolerability and incidence of adverse events(56 days)
- change of Female Sexual Distress Scale-Revised(56 days)