A Comparison of Hormonal Therapy: Tapering Regimens for Mediating Hot Flashes
试验速览
- 阶段
- 不适用
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- To evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen.
研究概览
简要总结
This study will evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen. Secondarily, we hope to evaluate whether there is a difference in the frequency (number of occurrences per week), severity (defined as a subjective scale mild, moderate, or severe), and "Severity Index" (SI, equaling the product of both) of hot flashes between three tapering schedules for one accepted HT/ET regimen.
详细描述
A Comparison of Hormonal Therapy:
Tapering Regimens for Mediating Hot Flashes
Clinicians have been asking for years whether a tapering dose of HT would make a difference in the frequency and severity of vasomotor symptoms after menopausal women stop HT therapy. This planned randomized, placebo-controlled trial (RCT) seeks to evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen. Secondarily, we hope to evaluate whether there is a difference in the frequency (number of occurrences per week), severity (defined as a subjective scale mild, moderate, or severe), and "Severity Index" (SI, equaling the product of both) of hot flashes between three tapering schedules for one accepted HT/ET regimen.
All participants will be randomized to one of the three arms (taper arm, placebo arm, and "cold turkey" arm). Each patient's gynecologist will be aware of the patient's involvement in the study and will assist by providing baseline safety information. All patients will be taken off their current HT/ET regimen and will be placed on study medication (1 mg of Estradiol PO every day for 8 weeks, "stabilization" phase). After the 8-week stabilization period, all participants will begin the therapy corresponding to the arm to which they were randomized. Each patient in the taper or placebo arm will take one capsule per day. The patients in the "cold turkey" arm will discontinued acutely after the stabilization.
The patients will keep a diary of the number and frequency of symptoms during the study. Patients will be contacted by phone to confirm that they are completing their diaries and that they have not developed side effects or complications that could force their discontinuation from the study.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ages 35-70, inclusive.
- •Postmenopausal (Natural or surgical: see definitions).
- •Currently on HT/ET for at least 6 months for vasomotor symptomatology.
- •Vasomotor symptoms are currently controlled on medication .
- •An annual physical & pelvic exam has been performed within the last 12mo
- •The patient has had a normal mammogram(BIRADS I/II) within the last 24mo
排除标准
- •Hypertension, defined as either SBP >140 mmHg or DBP >90 mmHg
- •Lack of compliance (willingness to adhere to protocol)
- •Inability or unwillingness to swallow pills
- •Patients with any contraindications to HT/ET
研究组 & 干预措施
1
Group A will be tapered over 4 weeks, starting at baseline (week 0). Subjects in this group will take one tablet of ET daily (effective dose, 0.75 mg) for week 1, then one 0.50 mg tablet daily for week 2, then one 0.25 mg tablet daily for week 3, and finally one 0.125 mg tablet daily for week 4.
干预措施: Estradiol (Drug)
2
Group B will be administered placebo. These tablets will appear identical to those administered to subjects in Group A, but the tablets will contain no estrogen. Subjects in this group will be instructed to take one pill every day for the 4 weeks. Thus, while patients will, in effect, be stopped abruptly from their therapy, there is still the potential of a placebo effect.
干预措施: Estradiol (Drug)
3
Group C will have their therapy discontinued acutely at baseline (week 0); i.e., these subjects will not take any tablets after the 8-week stabilization phase ends. While we recognize that this group will not be blinded to the regimen they are receiving, we feel that group C will be important to include in light of the consistent decrease in vasomotor symptoms experienced by women taking placebo. Because women taking placebo have approximately a 35% decrease in vasomotor symptoms, it will be important to compare our taper regimen to the "real life" scenario of stopping medication abruptly.
干预措施: Estradiol (Drug)
结局指标
主要结局
To evaluate whether there is a difference in the proportion of women who report a worsening severity of their hot flashes between three tapering schedules for one accepted HT/ET regimen.
时间窗: During the tapering and post taper time period.
次要结局
- frequency, severity, and "Severity Index" of hot flashes.(During the tapering and post taper time period.)