EFFICACY AND SAFETY OF SPIL'S ESTRADIOL VAGINAL TABLET, 10 MCG ESTRADIOL IN SUBJECTS WITH VULVAR AND VAGINAL ATROPHY: A RANDOMIZED, OBSERVER BLIND, PARALLEL GROUPS, ACTIVE AND PLACEBO CONTROLLED, CLINICAL ENDPOINT BIOEQUIVALENCE STUDY
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Vaginal pH
研究概览
简要总结
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol.
The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen.
The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.
详细描述
Estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic vaginitis due to estrogen deficiency.
This is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (Estradiol vaginal tablet, 10mcg of Sun Pharmaceutical Industries Ltd. India) relative to reference (Vagifem®, Estradiol vaginal tablet, 10mcg estradiol of Novo Nordisk) in treatment of vulvar and vaginal atrophy.
The patients will be administered with one tablet intravaginally daily for 14 days.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal woman
- •At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy
- •≤ 5% superficial cells on vaginal smear cytology
- •Vaginal pH > 5.0
排除标准
- •Consumption of estrogen alone or estrogen/progestin containing drug products.
- •Allergy to estradiol or related products
- •History of breast cancer and significant risk factors for endometrial cancer
- •Abnormal genital bleeding
研究组 & 干预措施
Estradiol
Intravaginal self-administration of study medication once daily for 14 days.
干预措施: Estradiol (Drug)
Reference: Estradiol
Intravaginal self-administration of study medication once daily for 14 days.
干预措施: Estradiol (Drug)
Placebo
Intravaginal self-administration of study medication once daily for 14 days.
干预措施: Estradiol (Drug)
结局指标
主要结局
Vaginal pH
时间窗: 14 days
次要结局
- Symptoms of vulvar and vaginal atrophy(14 days)