A Phase 2, Single-Center, Open-Label, Randomized, Controlled, Pharmacodynamic Study to Compare DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adequate endometrial transformation
研究概览
简要总结
This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.
详细描述
This is a 2-arm, single-center, open-label, randomized, active-controlled study to compare the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel over an 18-day treatment period. Patients will also be required to use an estrogen patch during the course of the study. The overall study duration for each patient will be approximately 1½ months.
Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26. In addition, serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Not pregnant
- •Clinically or medically-induced non-functioning or surgically removed ovaries
- •Clinical investigator believes patient would be eligible for oocyte donation
排除标准
- •Any contraindication to progesterone or estrogen therapy
- •Undiagnosed vaginal bleeding
- •History of uterine fibroids or any other conditions that could adversely affect pregnancy success
- •Hysterectomy
- •Any contraindication to vaginal drug delivery systems
研究组 & 干预措施
1
干预措施: DR-2011 (Drug)
2
干预措施: Progesterone 8% Vaginal Gel (Drug)
结局指标
主要结局
Adequate endometrial transformation
时间窗: Cycle Day 25 or 26
次要结局
- Hormone levels(Duration of study)