Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 22
- 主要终点
- Compare the efficacy of the three regimens
研究概览
简要总结
RATIONALE: Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes. It is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving hot flashes.
PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes.
详细描述
OBJECTIVES:
- Compare the efficacy of medroxyprogesterone administered as 1 injection vs medroxyprogesterone administered as 3 injections (closed to accrual as of 1/22/03) vs venlafaxine for hot flash alleviation in women with symptomatic hot flashes.
- Compare the toxic effects of these regimens in these patients.
- Determine whether there is cross resistance between these 2 drugs in these patients.
- Compare the 1-year efficacy of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (18 to 49 vs 50 and over), current tamoxifen use (yes vs no), current raloxifene use (yes vs no), duration of hot flash symptoms (less than 9 months vs 9 months or more), and average frequency of hot flashes per day (2-3 vs 4-9 vs 10 or more). Patients are randomized to 1 of 2 treatment arms. (Arm II closed to accrual as of 1/22/03.)
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients are randomized to one of three treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I: venlafaxine
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients receive oral venlafaxine once daily for 6 weeks beginning on day 8. After week 7, patients with satisfactory efficacy may continue venlafaxine for up to 6 months. Patients with unsatisfactory efficacy may cross over to arm III.
Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
干预措施: venlafaxine (Drug)
Arm II: medroxyprogesterone - long term
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients receive medroxyprogesterone intramuscularly (IM) on days 8, 22, and 36 for a total of 3 injections. After week 7, patients with unsatisfactory efficacy may cross over to arm I.
Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
干预措施: medroxyprogesterone (Drug)
Arm III: medroxyprogesterone - short term
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients receive medroxyprogesterone IM once on day 8. After week 7, patients with unsatisfactory efficacy may cross over to arm I.
Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
干预措施: medroxyprogesterone (Drug)
结局指标
主要结局
Compare the efficacy of the three regimens
时间窗: Up to one year post-treatment
次要结局
- Determine whether there is cross resistance between these 2 drugs in these patients(Up to 1 year post-treatment)
- Compare the 1-year efficacy of these regimens in these patients(Up to 1 year post-treatment)