Open Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device Ainara® Vaginal Gel, In Post-Menopausal Women Affected By Vaginal Dryness
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
- Visual Analogue Scale (VAS)
研究概览
简要总结
This study evaluates treatment with the medical device Ainara on the improvement of vaginal dryness evaluated by Vaginal Health Index (VHI) and Visual Analog Scale (VAS) in comparison with the baseline condition.
详细描述
Detailed Description: This is an open, non-comparative, multicenter study that evaluates the performance and safety of the medical device Ainara.
In this study the investigators use polycarbophilic vaginal moisturizing gel (Ainara) for symptomatic treatment of vaginal dryness and monitor its impact on vaginal dryness symptoms.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women (total cessation of menses for ≥ 1 year) according to the STRAW criteria, aged ≥ 50 to ≤ 70 years;
- •Diagnosis of vaginal dryness by:
- •Subjective dryness, any objective sign of VVA, pH>5 as reported in the AGATA study
- •Body mass index (BMI) ≥ 18.5 to ≤ 36 kg/m2;
- •Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
- •Capable of and freely willing to provide written informed consent prior to participating in the study.
排除标准
- •Malignancy (also leukemic infiltrates) within 5 years prior to Day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
- •Genital bleeding.
- •Estrogen vaginal treatment during the study period (it was permitted only if terminated at least 6 months before study).
- •Systemic estrogen therapy (it was permitted only if terminated at least 6 months before study).
- •Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study or be likely to lead to hospitalization during the course of the study.
- •Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e. tuberculosis).
- •Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
- •Known allergy to tested IMDs or its excipients.
- •Drug or alcohol abuse in the 12 months prior to Day
- •Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
- •Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 30 days
Visual Analogue Scale: the changing from baseline to day 3, 7, 21, 30 (final visit) for VAS mean value; The minim score is 0 and the maxim score is 5, where 0 represents no symptoms and 3 represents severe symptoms
Vaginal Health Index (VHI)
时间窗: 30 days
Vaginal Health Index: the changing from baseline to day 30 (final visit) for VHI mean value; The minim score is 5 and the maxim is is 25. For a patient to be included in study, the score must be lower than 15
次要结局
- Investigator Global Assessment of Safety (IGAS)(Time frame: 30 days)
- subjective symptoms(30 days)
- Vaginal pH(30 days)
- Female Sexual Function Index (FSFI)(30 days)
- Global Symptom Score (GSS)(30 days)
- Patient Global Assessment of Safety (PGAS)(30 days)
- Vaginal Trophism Maturation Value (MV)(30 days)
- objective signs in the vaginal mucosa(30 days)
- Sexual Function (SF 12)(30 days)
- AE, ADE, SAE, SADE(30 days)