Clinical Study to Compare the Efficacy of 1 Series of 2 Treatment Sessions With Erbium-Yag Laser or CO2RE Intimate Laser vs Sham (Sham Treatment) for Vulvovaginal Atrophy (Dryness and / or Dyspareunia)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy
研究概览
简要总结
This trial compares the efficacy of two different laser treatments for vaginal atrophy symptoms between them and with sham treatment. Patients will be randomized to one of the two lasers or sham treatment.
详细描述
Patients over 45 years of age with one or more AVV symptoms who wish to participate in the study will be included, 2 laser sessions spaced one of another 4-6 weeks, and final tracking visit 4-6 weeks of the last laser session.
Each patient shall be randomly assigned an arm of tto, with laser CO2, or laser Erbium, or sham group
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
- Single (Care Provider)
盲法说明
It is a single blind study
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 45 years with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.
排除标准
- •Hormone treatment in the last three months for vulvovaginal atrophy
- •Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
- •Laser treatment in the last 12 months.
- •Acute and recurrent infections of the urinary tract in the last 3 months.
- •Acute genital infections
- •Vaginal prolapse
- •Alterations in the area to be treated, such as lacerations, abrasions or ulcers (time of resolution at medical discretion)
- •Chronic decompensated noncommunicable diseases
- •Women who are pregnant or have given birth in the last 3 months
结局指标
主要结局
Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy
时间窗: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)
Analyzing the differences in % the cytological maturity index, changes in the intensity of symptoms and PH range of normality (3,5- 4.5).
次要结局
- Differences between CO2RE and Erbium-Yag(Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks))
- Changes in the Vulvar and Vaginal Health Index (VVHI)(Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks))