Pilot Clinical Trial on the Efficacy and Safety of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 4
- 主要终点
- Safety of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA) measuring the incidence, nature and severity of adverse events (AE).
研究概览
简要总结
Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.
详细描述
Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.
Open study with only one arm. The study has a total duration per patient of 3 months: initial visit (V1), a follow-up visit (V2) after 4 weeks of treatment and a final visit (V3) after 12 weeks of treatment.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who attend medical centers, either for a visit related to vulvovaginal atrophy (VVA) or for any other reason for consultation, with symptoms of VVA (dryness and / or dyspareunia) of moderate or severe intensity (score 2-3 on the Likert scale).
- •Women between the ages of 40 and 65, inclusive, in the peri- or postmenopausal period.
- •Women are able to understand and sign the informed consent after the nature of the study has been fully explained to them.
排除标准
- •Pregnant or immediate postpartum patients (up to 40 days).
- •Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatment.
- •Use of any other experimental drug or device during the 30 days prior to screening.
- •Use of topical antibiotics or antifungals applied vaginally in the two weeks prior to the initial visit.
- •Use of contraceptives for vaginal application.
- •Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.)
- •Undiagnosed abnormal genital bleeding or presence of vaginal lesion.
- •Active genitourinary infections at the time of inclusion or in the 15 days prior to inclusion in the study.
- •Impossibility, at the discretion of the researcher, to comply with the requirements of the study, either due to follow-up problems, or due to their psychophysical characteristics.
研究组 & 干预措施
Idracare
The treatment will be applied 2 times a week, preferably at night before going to bed.
干预措施: Idracare (Device)
结局指标
主要结局
Safety of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA) measuring the incidence, nature and severity of adverse events (AE).
时间窗: Through study completion, an average of 12 weeks
To evaluate the safety of Idracare® gel, the incidence, nature and severity of adverse events (AE) will be studied.
Efficacy of Idracare® in the treatment of symptoms of vulvovaginal atrophy (VVA)
时间窗: Through study completion, an average of 12 weeks
To evaluate the efficacy of the Idracare® gel as a treatment for the symptoms of VVA, the percentage of women who present changes in dryness and / or dyspareunia has been established as the main variable.
次要结局
- To evaluate the effect of Idracare® gel using vulvar health index (VHI).(4 and 12 weeks)
- To evaluate the effect of Idracare® gel using maturation of vaginal epithelial cells.(4 and 12 weeks)
- To evaluate the effect of Idracare® gel using Bachmann Vaginal Health Index (BVHI).(4 and 12 weeks)
- To evaluate the effect of Idracare® gel using vaginal microbiota.(4 and 12 weeks)
- The degree of satisfaction with the use of Idracare®(4 and 12 weeks)
- To evaluate the effect of Idracare® gel using vaginal pH(4 and 12 weeks)
- The tolerability of the treatment using a 5-point Likert-type scale(4 and 12 weeks)