NCT03740945撤回3 期
Effect of Intravaginal Prasterone (DHEA) on Moderate to Severe Symptoms of Vulvovaginal Atrophy Due to Menopause, in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer - (Placebo-Controlled, Double Blind and Randomized Phase III Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Change from Baseline to Week 12 in the Percentage of Superficial Cells
研究概览
简要总结
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Main criteria:
- •Natural, surgically- or treatment-induced postmenopausal women (non hysterectomized or hysterectomized) with breast cancer (stage 1 or 2) who is currently under treatment with an aromatase inhibitor and will remain on that treatment for the duration of the study.
- •Women between 30 and 80 years of age
- •Women having ≤5% of superficial cells on vaginal smear at baseline
- •Women having a vaginal pH above 5 at baseline
- •Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
排除标准
- •Main criteria:
- •Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
- •The administration of any investigational drug within 30 days of screening visit
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo vaginal ovule daily for 12 weeks
干预措施: Placebo (Drug)
Prasterone
Experimental
Prasterone (DHEA) vaginal ovule daily for 12 weeks
干预措施: Prasterone (DHEA) (Drug)
结局指标
主要结局
Change from Baseline to Week 12 in the Percentage of Superficial Cells
时间窗: 12 weeks
Change from Baseline to Week 12 in the Percentage of Parabasal Cells
时间窗: 12 weeks
Change from Baseline to Week 12 in Vaginal pH
时间窗: 12 weeks
Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS)
时间窗: 12 weeks
次要结局
- Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome)(12 weeks)
- Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire(12 weeks)
- Change from Baseline to Week 12 on subjective arousal domain of FSFI(12 weeks)
- Change from Baseline to Week 12 on desire domain of FSFI(12 weeks)
- Change from Baseline to Week 12 on satisfaction domain of FSFI(12 weeks)
- Change from Baseline to Week 12 on orgasm domain of FSFI(12 weeks)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions(12 weeks)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness(12 weeks)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity(12 weeks)
- Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color(12 weeks)
研究者
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