Open, Comparative Study To Evaluate The Performance And Safety Of The Medical Device AINARA® Vaginal Gel Versus A Hyaluronic Acid-Based Gel In Late Menopausal Transition 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
- 2
- 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® compared to a HA-based gel (Hyalogin) on the improvement of vaginal dryness
详细描述
This is an open, comparative, multicenter study that evaluates the performance and safety of the medical device Ainara®.
In this study we use polycarbophilic vaginal moisturizing gel (Ainara®) compared with a HA-based gel (Hyalogin) for symptomatic treatment of vaginal dryness and we will monitor its impact on vaginal dryness symptoms evaluated by Vaginal Health Index and Vaginal Analogue Scale.
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
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant and in menopausal transition period (late peri-menopause) women following the STRAW criteria and with a break in menstrual periods of at least 60 days, aged ≥ 45 to ≤ 55 years.
- •Diagnosis of vaginal dryness by subjective dryness, any objective sign of VVA, pH>5 as reported in the AGATA study and VHI <
- •Body mass index of ≥ 18.5 to ≤ 36 kg/m
- •Females of child bearing potential who agree to use only lubricated condoms or spiral as contraceptives methods, during the full duration of the study.
- •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
- •Women in post-menopausal (total cessation of menses for ≥ 1 year from the date of the screening visit).
- •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 (permitted only if terminated at least 6 months before study).
- •Systemic estrogen therapy (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 course of the study.
- •Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhoea, 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 within 12 months of 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
The changing from baseline to day 3, 7, 21, 30 (final visit) for VAS mean value in each group separately and in the Ainara® group in comparison with that occurred in HyaloGyn® group. The minim score is 0 and the maxim score is 5, where 0 represents no symptoms and 3 represents severe symptoms
The Vaginal Health Index (VHI)
时间窗: 30 days
The changing from baseline to day 30 (final visit) for VHI mean value in each group separately and the changing in the Ainara® group in comparison with that occurred in HyaloGyn® group; The minim score is 5 and the maxim is is 25
次要结局
- Female Sexual Function Index (FSFI)(30 days)
- objective signs in the vaginal mucosa(30 days)
- subjective symptoms(30 days)
- Vaginal pH(30 days)
- Global Symptom Score (GSS)(30 days)
- Sexual Function (SF 12)(30 days)
- Adverse Event, Adverse Device Event, Serious Adverse Event, Suspected Adverse Device Event(30 days)
- Vaginal Trophism Maturation Value (MV)(30 days)
- Patient Global Assessment of Safety (PGAS)(30 days)
- Investigator Global Assessment of Safety (IGAS)(30 days)