Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
研究概览
简要总结
A prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / or vestibular pain. The efficacy of Prasterone treatment is evaluated in those patients willing to undergo the treatment compared to the control group.
详细描述
A sample of 50 women over 45 years of age with at least one year of amenorrhea and who require treatment for vulvovaginal atrophy of moderate and / or severe intensity and who present vulvar and vaginal pain within these symptoms will be chosen.
At the beginning of the study, after passing the selection criteria and signing the informed consent, the patients will be randomly assigned to one of the two arms of the study, (active group) or (control group), said assignment will be made randomly. Through a computer program where one or the other arm of treatment will be assigned to the patient at random to guarantee the homogeneity of both study groups and thus avoid selection biases.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over 45 years of age with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.
- •Women with moderate to severe vulvar / vestibular pain
- •Women without symptoms or signs of acute vaginal infection.
- •Women without symptoms of urinary infection and a negative urine strip result.
- •Woman willing to carry out the study procedures and comply with the visits.
- •Woman who signs the Informed Consent.
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 6 months.
- •Acute and recurrent urinary tract infections in the last 3 months.
- •Acute genital infections (herpes, candida, etc)
- •Personal history of cancer at any level
- •Present alterations in the area to be treated, such as lacerations, abrasions or ulcers (resolution time at the medical discretion)
- •Decompensated non-communicable chronic diseases (Diabetes Mellitus, Heart Disease ...)
- •Participation in a clinical study 3 months before inclusion or during this study.
- •Hypersensitivity to the active principle or any of the excipients
- •Undiagnosed vaginal bleeding.
- •Untreated endometrial hyperplasia
- •Acute liver disease or a history of liver disease while liver function tests remain impaired.
- •Current diagnosis or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism)
- •Known thrombophilic disorders (protein C, protein S, or antithrombin deficiency)
- •Current or recent diagnosis of arterial thromboembolic disease (angina, myocardial infarction)
- •Porphyria
研究组 & 干预措施
Active Treatment
Patients who will undergo treatment with Intrarosa (Prasterone 6.5mg) in ovules, will apply one ovule a day before going to bed for 12 weeks.
干预措施: Prasterone 6.5 MG (Drug)
Control Group
Patients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
时间窗: Visit 3 (Week 12)
Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain.
次要结局
- Evaluation of vulvovaginal vascularization(Screening visit 1 (Day 0); Visit 3 (Week 12))
- Evaluation of vulvo vestibular pain(Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12))
- Evaluation of Ph and cytological maturity index(Screening Visit 1 (Day 0); Visit 3 (Week 12))
- Evaluation of the clinical index of vulvar and vaginal health(Screening Visit 1 (Day 0); Visit 3 (Week 12))
研究者
Dr. Santiago Palacios
Investigador Principal
Instituto Palacios