A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mean change in maturation index
研究概览
简要总结
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
详细描述
The study will include a screening period up to 4 weeks and a 12-week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.
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
- Double (Participant, Investigator)
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
- •Naturally or surgically postmenopausal
- •Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
排除标准
- •Known sensitivity or contraindication to estrogens or progestins
- •History or current diagnosis of endometrial hyperplasia
- •Recent history of vaginal bleeding of unknown cause
- •Recent history or diagnosis of endometriosis
- •Any contraindication to estrogen therapy
研究组 & 干预措施
1
干预措施: Synthetic Conjugated estrogens, B (Drug)
2
干预措施: Placebo (Other)
结局指标
主要结局
Mean change in maturation index
时间窗: Randomization to Week 12
Mean change in the symptom identified by the patient to be most bothersome
时间窗: Randomization to Week 12
Mean change in vaginal pH
时间窗: Randomization to Week 12
次要结局
- Safety and tolerability of Enjuvia(Duration of study)