The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of Participants With Nausea During the First 2 Weeks of Treatment
研究概览
简要总结
Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
- •Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL.
排除标准
- •History of a seizure disorder other than a single childhood febrile seizure.
- •History or presence of clinically important hepatic or renal disease or other medical disease.
- •Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
研究组 & 干预措施
A
干预措施: desvenlafaxine succinate sustained release (Drug)
B
干预措施: desvenlafaxine succinate sustained release (Drug)
C
干预措施: desvenlafaxine succinate sustained release (Drug)
D
干预措施: desvenlafaxine succinate sustained release (Drug)
E
干预措施: Placebo (Drug)
F
干预措施: desvenlafaxine succinate sustained release (Drug)
G
干预措施: desvenlafaxine succinate sustained release (Drug)
H
干预措施: desvenlafaxine succinate sustained release (Drug)
结局指标
主要结局
Number of Participants With Nausea During the First 2 Weeks of Treatment
时间窗: Baseline up to Week 2
Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.
Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering
时间窗: Week 17
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
DESS Total Score at End of Second Week of Tapering
时间窗: Week 18
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
DESS Total Score at 1 Week After the End of Tapering
时间窗: Week 19
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
次要结局
- Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment(Baseline up to Week 2)
- Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment(Baseline up to Week 2)
- Number of Participants With Each DESS at the End of First Week of Tapering(Week 17)
- Number of Participants With Each DESS at the End of Second Week of Tapering(Week 18)
- Number of Participants With Each DESS One Week After End of Tapering(Week 19)
- Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment(Week 1 and Week 2)
- Number of Participants Showing Satisfaction With Tolerability at the End of Tapering(Week 19)
- Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score(Week 16)
- Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16(Baseline, Week 4, Week 8, Week 12 and Week 16)