Effect of Intravaginal Prasterone on Genitourinary Syndrome in Women in Menopause With Previous Breast Cancer or Currently Under Treatment With Endocrine Therapy for Breast Cancer With Aromatase Inhibitor +/- LHRHa
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Establish subjective improvement in genitourinary symptomatology at intervals marked by the study
研究概览
简要总结
The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with Breast Cancer. A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. Subjects will be followed up at four weeks and twelve weeks of treatment. One and three-month outcomes will be provided after the end of treatment. Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed breast cancer, completely excised
- •Natural or iatrogenic menopausal status
- •No evidence of distant metastasis
- •Self-identified moderate to severe symptoms of genitourinary syndrome
- •Normal kidney and liver function
- •Written Informed Consent signed and dated by patient
- •Negative Papanicolau (Pap) Smear Cytology Test within 1 year prior to enrollment
排除标准
- •Vaginal or uterine bleeding of unknown origin
- •Current diagnosis of any non-breast malignancy
- •Metastatic disease
- •Currently on chemiotherapy
- •Currently on treatment with tamoxifen
- •Mentally incompetent or evidence of active substance or alcohol abuse
- •Endometrial hyperplasia
- •Pregnancy or lactation
- •Currently use of other vaginal therapy for the same purpose (if present, they have to be stopped 15 days before baseline visit)
- •Clinically significant metabolic or endocrine disease not controlled by medication
研究组 & 干预措施
intravaginal Prasterone
干预措施: Prasterone (DHEA) (Drug)
结局指标
主要结局
Establish subjective improvement in genitourinary symptomatology at intervals marked by the study
时间窗: From enrollment to after 3 months after the end of treatment
To establish the improvement in vulvovaginal and urinary symptoms, by subjective evaluation at baseline, at 12 weeks and after 1 and 3 months after the end of the treatment. Establish tissue trophism improvement through gynecological evaluation, the use of validated scales (Vaginal Health Index), and determination of the maturation index on vaginal spatula, measure serum estradiol during and after treatment
evaluation of vulvovaginal and urinary symptoms
时间窗: 6 months
evaluation of vaginal dryness, dyspareunia, pruritis, burning and dysuria with a 0 to 4 score (0: absence, 1: mild, 2: moderate, 3: severe, 4: very severe)
improvement in vaginal signs
时间窗: 6 months
To establish the improvement in vaginal signs using the Vaginal Health Index Scale (VHI)
evaluation fo maturation index
时间窗: 6 months
To assess the maturation index (as percentage of superficial, intermediate and parabasal cells) in the vaginal mucosa
grade of satisfaction
时间窗: 6 months
To report the grade of satisfaction as measured by the Global Response Assessment at the end of the study
次要结局
未报告次要终点