A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) Administered for 14 Days and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 522
- 试验地点
- 1
- 主要终点
- The proportion of subjects with at least 25% reduction from baseline in the sum of % basal/parabasal + %intermediate cells on vaginal cytology and vaginal pH <5.0 with a change from baseline vaginal pH of at least 0.5
研究概览
简要总结
This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female postmenopausal subjects aged >30 to <75 years
- •At least 1 subject assessed moderate to severe symptom of vulvar and vaginal atrophy among the following that is identified as being the most bothersome to her
- •vaginal dryness
- •vaginal and/or vulvar irritation/ itching
- •vaginal pain associated with sexual activity
- •presence of vaginal bleeding associated with sexual activity
- •Have <5% superficial cells on vaginal smear cytology and vaginal pH >5.0 at Visit 1
- •Systolic blood pressure <150mm Hg and diastolic blood pressure <90mm Hg at Visit 1
排除标准
- •Known hypersensitivity to Estradiol vaginal tablet
- •Screening mammogram or clinical breast examination results indicating any suspicion of breast malignancy.
- •History of undiagnosed vaginal bleeding.
- •History of significant risk factors for endometrial cancer
- •For women with an intact uterus, screening vaginal ultrasonography showing endometrial thickness of ≥ 4 mm.
研究组 & 干预措施
Estradiol Vaginal Tablets 10 mcg (Glenmark)
apply using the given applicator
干预措施: Estradiol Vaginal Tablets 10 mcg (Glenmark) (Drug)
Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)
apply using the given applicator
干预措施: Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk) (Drug)
Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)
apply using the given applicator
干预措施: Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark) (Drug)
结局指标
主要结局
The proportion of subjects with at least 25% reduction from baseline in the sum of % basal/parabasal + %intermediate cells on vaginal cytology and vaginal pH <5.0 with a change from baseline vaginal pH of at least 0.5
时间窗: Day 15]
次要结局
- The proportion of subjects with treatment success at the end of study where treatment success is defined as a subject who achieves a score of 0 (none) or 1 (mild) at Visit 3/End of Study for the MBS(Day 15])