A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 622
- 试验地点
- 1
- 主要终点
- Mean Change in Vaginal pH
研究概览
简要总结
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on 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 menopausal
- •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 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
3
干预措施: Placebo (Other)
1
干预措施: DR-2041a (Drug)
2
干预措施: DR-2041b (Drug)
4
干预措施: Placebo (Other)
结局指标
主要结局
Mean Change in Vaginal pH
时间窗: Baseline to Week 12
Change= Week 12 vaginal pH - Baseline vaginal pH
Mean Change in the Symptom Identified by the Patient to be Most Bothersome
时间窗: Baseline to Week 12
Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.
Mean Change in Maturation Index
时间窗: Baseline to Week 12
Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells \* 0) + (% Intermediate Cells \* 0.5) + (% Superficial Cells \* 1.0)
次要结局
- Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)(Up to Week 12)