Natural Topical Treatment for Vulvar and Vaginal Atrophy: a Single-center Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in vaginal health index score
研究概览
简要总结
Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.
详细描述
The aim of this prospective observational study is to evaluate safety and efficacy of Zantogin® Gel (ZG) a class II medical device developed for intravaginal use in the treatment of signs and symptoms of post-menopausal vulvovaginal atrophy (VVA), in terms of improvement of objective parameters assessing vaginal health (Vaginal Health Index score) and subsequent patients' sexual quality of life (Female Sexual Distress Scale).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 45-65 years
- •Menopause and symptomatic vulvovaginal atrophy (VVA) (vaginal dryness, dyspareunia, vaginal irritation, vaginal itching, dysuria)
- •No previous treatment for VVA
- •Informed written consent signed
排除标准
- •Pregnancy
- •Previous or concurrent neoplasms
- •Uncompensated concomitant diseases (i.e., diabetes, cardiac diseases)
- •Previous or concurrent Hormone replacement therapy (HRT) or radiotherapy or chemotherapy.
结局指标
主要结局
Change in vaginal health index score
时间窗: 5.5 months
Scale score range is 5-25. The minimum 5 points core indicates severe vulvovaginal atrophy and the maximum total score of 25 points indicates no clinical signs of vulvovaginal atrophy.
Change in Female Sexual Distress Scale (FSD)
时间窗: 5.5 months
A score of ≥11 effectively discriminates between women with FSD and no FSD.
次要结局
未报告次要终点
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences