Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cessation of Bleeding Within 5 Days
研究概览
简要总结
The purpose of this study is to investigate the effectiveness and acceptability of high dose MPA (20mg oral 3 times a day) for 3 days combined with an injection of DMPA 150 mg intramuscularly in the treatment of acute heavy, prolonged uterine bleeding who have been identified as being eligible for outpatient management
详细描述
Excessive vaginal bleeding is a frequent problem for reproductive age women and accounts for many office and emergency room visits. This bleeding is caused by cancer, endocrinologic problems, liver failure, benign tumors of the uterus, and cervix, as well as hormone imbalances, such as anovulatory cycling.
Even though excessive vaginal bleeding is very common, there has been very little research into ways to manage it. For non-pregnant women who have stable vital signs and are not hemorrhaging or experiencing severe anemia, outpatient therapy is generally attempted. Textbooks recommend treatment with high dose oral contraceptives pills (one tablet orally 2 times a day for 5 days). Recently, Munro et al published a small study using high doses of oral progestin (MPA 20mg 3 times daily for 7 days then one daily for 21 days). The median time to bleeding cessation was 3 days. Munro reported having difficulty enrolling adequate numbers of patients to achieve the statistical significance.
The investigators propose a pilot project to study clinical responses to a new hormonal therapy the blends the high dose oral therapy with the longer acting injectable progestin. The pilot clinical trial is designed to study 50 women who are bleeding and whose treatment is amenable to outpatient therapy. Routine care will be provided to each of the women before she is approached for study enrollment.
This study, therefore, is designed to provide short term proven therapy of 20 mg MPA tablets 3 times a day for 3 days combined with the injectable progestin (DMPA) that lasts for 3 months.
Patients will be called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they may be experiencing. Patients will be asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who are still having any bleeding on day 3 will be contacted on day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Age 18- 50
- •Non-pregnant
- •Candidate for outpatient management
- •Able to understand and follow instructions
- •Vital signs stable
- •No severe anemia
- •No medical conditions requiring transfusion
排除标准
- •Pregnancy
- •Breast cancer current or in last 5 years
- •Allergy to MPA or DMPA
- •Previous hormonal therapies
- •Unstable vital signs
- •Bleeding excessive enough to require surgical therapy or hospital admission
- •Desire for pregnancy in next 6 months
研究组 & 干预措施
DMPA & MPA
150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days
干预措施: Medroxyprogesterone 17-Acetate (Drug)
DMPA & MPA
150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days
干预措施: medroxyprogesterone acetate (Drug)
结局指标
主要结局
Cessation of Bleeding Within 5 Days
时间窗: 3-5 days
Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5
次要结局
- Patient Perception of the Acceptability of the Treatment(End of the trial; up to day 5)
- Satisfaction and Willingness to Recommend Treatment(End of the trial; up to day 5)
研究者
Anita Nelson
Medical Director
Women's Health Care Clinic, Torrance, California