Efficacy Study Comparing 0.9 g and 1.25 g EstroGel® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 109
研究概览
简要总结
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
详细描述
The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 45-65 years
- •naturally or surgically postmenopausal
- •experiencing hot flushes
排除标准
- •hypersensitivity to estrogen replacement therapy
- •pregnancy or lactating
- •abnormal PAP smear
- •history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy
研究组 & 干预措施
EstroGel® Gel 0.9 grams 0.03%
0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
干预措施: Estrogel (Drug)
EstroGel® Gel 1.25 grams 0.03%
1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks.
干预措施: Estrogel (Drug)
Placebo Gel
0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
干预措施: Placebo (Other)