A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
研究概览
简要总结
This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.
详细描述
In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Not pregnant
- •Secondary amenorrhea or oligomenorrhea of at least 50 days duration
- •Not currently on any hormonal medication
- •Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom)
排除标准
- •Use an injectable or implantable estrogens, progestins, or androgens within the last 6 months
- •Use of any hormonal birth control within the last 3 months
- •Any contraindication to the use of progestins
研究组 & 干预措施
1
干预措施: DR-2021a (Drug)
2
干预措施: DR-2021b (Drug)
3
干预措施: DR-2021c (Drug)
4
干预措施: DR-2021d (Drug)
5
干预措施: DR-2021e (Drug)
6
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
时间窗: Throughout study period
次要结局
- Time to onset, duration, and severity of withdrawal bleeding.(Throughout study)