NCT04676061终止4 期
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™; a Randomized Double-Blinded Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Number of days of bleeding and spotting
研究概览
简要总结
Effects of norethindrone acetate (NTA) in patients with Nexplanon.
详细描述
The purpose of this study is to find out what effects norethindrone acetate (NTA) has on the duration and recurrence of frequent and/or prolonged bleeding associated with Nexplanon™.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Years 至 48 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18-48
- •Between ages of 14-17 with parental/guardian permission
- •Women desiring placement of Nexplanon™
- •Willing to keep a daily symptom calendar
- •Keep appointments
- •Women not desiring to become pregnant in the next 2 years
排除标准
- •Known or suspected Pregnancy
- •Less than 8weeks postpartum
- •Menarche less than two years ago
- •Current or past history of thrombosis or thromboembolic disorders
- •Hepatic tumors (benign or malignant)
- •Active liver disease
- •Undiagnosed abnormal genital bleeding
- •Undiagnosed headaches
- •Known or suspected carcinoma of the breast or personal history of breast cancer
- •Hypersensitivity to any of the components in Nexplanon™
- •BMI greater than 40
- •Depomedroxyprogesterone acetate injection in the previous 12 weeks
研究组 & 干预措施
Control Group
Placebo Comparator
Placebo to Norethindrone acetate (NTA)
干预措施: Placebo (Drug)
Treatment Group
Active Comparator
Norethindrone acetate (NTA)
干预措施: Norethindrone acetate (NTA) (Drug)
结局指标
主要结局
Number of days of bleeding and spotting
时间窗: 30 days
To evaluate days of bleeding and spotting within 90-day intervals by quantifying a self-perception of amount of bleeding on a scale of 0 to 4 and associated symptoms on a scale of 0 to 10 using the Daily Dairy of Symptoms
次要结局
- Quality of life measurements(30 days)
研究者
研究点 (1)
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