Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Frequency of VMS
研究概览
简要总结
The purpose of this study is to test whether a oral micronized progesterone reduces the Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats in perimenopausal women. Oral micronized progesterone is molecularly identical to human progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial cancer in women taking estrogen in menopause. This research study will test whether progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether progesterone improves sleep disturbances and anxiety.
详细描述
This is a randomized, double-blind placebo-controlled trial of oral micronized progesterone (300 mg daily at bedtime) for perimenopausal women living anywhere in Canada. Using the self-reported maximum menstrual cycle length in the previous year, women will be stratified as in Early Perimenopause (<60 days) or Late Perimenopause (>=60 days). The design includes a 28-day baseline run-in followed by 12 weeks of randomized therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 58 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 35-58 years of age
- •At least 4 vasomotor symptoms (VMS) per day, on average, for at least 2/4 weeks or at least 56 over a four-week period. In addition, women should report having VMS of moderate or severe rather than mild intensity. Women reporting fewer VMS than this, but who report night sweats that awaken them from sleep on two or more nights per week will also be included.
- •Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.
- •At least one menstrual period within 12 months of study enrollment
- •Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.
- •Ability to understand, speak, read and write English.
- •Women who are at high risk for breast cancer (ie first degree relative with breast cancer, known/suspected history of breast cancer) will be required to have a normal mammogram and clinical breast examination within 12 months of study enrollment.
排除标准
- •VMS without perimenopausal etiology.
- •Women who have had a hysterectomy and/or ovariectomy.
- •Peanut allergy (because peanut oil is used in the progesterone formulation.)
- •Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen, progesterone, hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period. Two exceptions: women using progestin-releasing intrauterine device (IUD) will not be excluded as it is felt that level of hormone released will not have an effect on VMS and women taking very low-dose transdermal progesterone therapies who have VMS and meet inclusion criteria will be considered on a case-by-case basis. If enrolled, women with these exclusion exceptions will be required to continue and document use of these therapies throughout the entire trial.
- •Planned pregnancy or fertility treatment during the study period.
- •Women who are breastfeeding.
- •Participants with a score greater or equal to 15 on the Personal Health Questionnaire (PHQ-9) will be assessed on a case-by-case basis. Women assessed as needing further investigation and/or treatment for depression will be excluded.
研究组 & 干预措施
oral micronized progesterone
Oral micronized progesterone is Prometrium 300 mg at bedtime daily
干预措施: Oral micronized progesterone (Drug)
Placebo Comparator
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Frequency of VMS
时间窗: 12 weeks
Frequency (count) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Outcome is the average daily VMS Frequency (day + night) during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
Severity of VMS
时间窗: 12 weeks
Severity (0-4, 0=no intensity, 4=extreme intensity) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Daily summary score is the maximum of daytime and nighttime severity. Outcome is the average daily severity during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
VMS Score by Early Perimenopause
时间窗: 12 weeks
subgroup analysis of VMS Score by Early Perimenopause (no skipped period or \<60 day cycle length). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score
时间窗: 12 weeks
VMS Score for those with more frequent (≥7 per day and moderate to severe episodes of intensity 2-4) at baseline. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks
时间窗: 12 weeks
Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
VMS Score by Late Perimenopause
时间窗: 12 weeks
subgroup analysis of VMS Score by Late Perimenopause (those with skipped or ≥60 day cycle lengths). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
次要结局
- Perception of Interference of Perimenopausal Mood Changes With Usual Activities in Women(12 weeks)
- Depression Related to Progesterone Therapy in Late Perimenopause(12 weeks)
- Women's Perceived Changes in Quality of Sleep for Whole Population(12 weeks)
- Depression Related to Progesterone Therapy in Whole Population(12 weeks)
- Percentage of Women With Perceived Changes in Menstrual Flow(12 weeks)
- Women's Perceived Changes in Daytime Hot Flushes for Whole Population(12 weeks)
- Women's Perceived Changes in Night Sweats for Whole Population(12 weeks)
- Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Early Perimenopause(12 weeks)
- Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Late Perimenopause(12 weeks)
- Anxiety(12 weeks)
- Women's Perceived Changes in Daytime Hot Flushes in Late Perimenopause(12 weeks)
- Women's Perceived Changes in Night Sweats in Late Perimenopause(12 weeks)
- Sleep Problems(12 weeks)
- Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women(12 weeks)
- Perception of Interference of Perimenopausal Body Changes With Usual Activities in Women(12 weeks)
- Women's Perceived Changes in Daytime Hot Flushes in Early Perimenopause(12 weeks)
- Women's Perceived Changes in Night Sweats in Early Perimenopause(12 weeks)
- Depression Related to Progesterone Therapy in Early Perimenopause(12 weeks)
研究者
Jerilynn Prior
Principal Investigator
University of British Columbia