NCT04355403已完成不适用
A Prospective, Randomized, Controlled, Open-label Clinical Investigation to Assess the Performance and Safety of Hyalo Gyn Gel Prefilled Applicators on the Treatment of Vaginal Atrophy in Postmenopausal Women
Fidia Farmaceutici s.p.a.4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年2月5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
- 80
- 试验地点
- 4
- 主要终点
- Change of patient's perception of vulvovaginal dryness
研究概览
简要总结
This clinical investigation evaluates the performance and safety of Hyalo Gyn, a hyaluronic acid derivative based vaginal gel 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
- 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 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), both natural postmenopause or medical postmenopause (breast cancer patients undergoing a concurrent treatment with aromatase inhibitors or tamoxifen).
- •Women between 18 and 75 years of age.
- •Vaginal pH ≥
- •Vulvovaginal atrophy with VHI <
- •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 life.
- •Patients who give written informed consent to participate in the trial.
排除标准
- •Treatment with another investigational product within the previous 3 months.
- •Previous participation in any clinical study with Hydeal-D based investigational products.
- •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); history of vulvovaginal contact allergy or with a diagnose of vulvovaginal lichen.
- •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.
- •Any condition in the investigator's opinion not suitable for the inclusion of the patient.
结局指标
主要结局
Change of patient's perception of vulvovaginal dryness
时间窗: From baseline to 12 weeks of treatment
Change of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. The vulvovaginal dryness was reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe).
次要结局
- Change of patient's perception of vulvovaginal symptoms(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 vaginal pH(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)
- Ease in the method of Hyalo Gyn gel administration(4 and 12 weeks of treatment)
- Change of patient's perception of vulvovaginal dryness(From baseline to 4 weeks of treatment)
- Change of the average score of Vaginal Health Index (VHI)(From baseline to 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)
- Patient's global assessment of overall satisfaction(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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