NCT03557398已完成不适用
Prospective Clinical Study to Assess the Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
Fidia Farmaceutici s.p.a.4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年11月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change of the average score of Vaginal Health Index (VHI)
研究概览
简要总结
This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/L, or had been surgically postmenopausal for more than 6 months)
- •Women between 45 and 75 years of age.
- •Vaginal pH ≥5
- •Vulvovaginal atrophy with VHI < 15
- •At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity
- •Women with active sex lives
- •Patients who give written informed consent to participate in the trial
排除标准
- •Enrollment in other clinical trials within the previous 1 month.
- •Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
- •Patients in previous treatment with either oral or topical hormonal products within 1 month.
- •Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); or history of vulgovaginal contact allergy.
- •Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
- •Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
- •Women with no active sex lives
- •Women who do not give informed consent;
- •Any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient
结局指标
主要结局
Change of the average score of Vaginal Health Index (VHI)
时间窗: From baseline to 12 weeks of treatment
Change of Vaginal Health Index (VHI) calculated on the basis of vaginal elasticity, vaginal fluid volume, vaginal pH, vaginal mucosa epithelial integrity, and vaginal moisture on a scale ranging from 1 (poorest) to 5 (best). VHI assigned score is the sum of subscores and ranges from 5 to 25. A lower score corresponds to a greater atrophy.
次要结局
- Patient's global assessment of overall satisfaction(4 and 12 weeks of treatment)
- Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)(From baseline to 4 and 12 weeks of treatment)
- Amelioration of the vaginal maturation (VM) index(From baseline to 12 weeks of treatment)
- Local tolerability at the application site(4 and 12 weeks of treatment)
- Change of the average score of Vaginal Health Index (VHI)(From baseline to 4 weeks of treatment)
- Change of vaginal pH(From baseline to 4 and 12 weeks of treatment)
- Change of patient's perception of vulvovaginal symptoms(From baseline to 4 and 12 weeks of treatment)
- Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)(From baseline to 4 and 12 weeks of treatment)
- Safety of the treatment: Collection of adverse events(4 and 12 weeks of treatment)
研究者
研究点 (4)
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