A Multicenter, Double-Blind, Controlled, Randomized Study to Compare the Efficacy in Relief of Hot Flushes in Women Receiving Oral Estradiol Acetate Tablets, Oral Estradiol Tablets or Oral Conjugated Equine Estrogens
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
- Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population
研究概览
简要总结
Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.
- •Non-hysterectomized women:
- •Amenorrhea for ≥ 12 months or
- •Amenorrhea for ≤ 12 months, but longer than 6 months, and serum FSH (follicle stimulating hormone) levels > 40 units/L and serum estradiol levels < 20 pg /mL,
- •Hysterectomized women:
- •Bilateral oophorectomy - subjects may enter the study 6 weeks after surgery or
- •History of removal of ovaries may be confirmed by - serum FSH levels > 40 units/L and serum estradiol levels < 20 pg/mL or via surgical report / ultrasound.
- •Seven or more moderate or severe hot flushes daily for 1 week or 60 or more moderate or severe flushes in 1 week during the 2 week screening period prior to study entry.
排除标准
- •Hormone therapy administered via the following routes and during the specified timeframes: oral within 8 weeks, vaginal (rings, creams, gels) within 1 week, transdermal within 4 weeks, intramuscular within 6 weeks, progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months, estrogen pellet or progestational injectable within 6 months.
- •Abnormal Pap smear suggestive of low grade squamous intraepithelial lesion (LGSIL) or worse. Enrollment of subjects with an ASCUS (atypical squamous cells of undetermined significance) interpretation must be discussed with the sponsor prior to randomization.
- •Urinary tract infection
- •Congestive heart failure
- •Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg
- •History of stroke or transient ischemic attacks
- •Treatment with anticoagulants (heparin or warfarin).
- •Uncontrolled thyroid disorders.
- •Insulin-dependent diabetes mellitus.
- •Increase frequency or severity of headaches including migraines during previous estrogen therapy.
研究组 & 干预措施
Estradiol acetate (E3A)
干预措施: Estradiol acetate (Drug)
Estradiol
干预措施: Estradiol (Drug)
Conjugated equine estrogens (CEE):
干预措施: Conjugated equine estrogens (Drug)
结局指标
主要结局
Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population
时间窗: Baseline to Week 4
Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep
Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population
时间窗: Baseline to Week 12
Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep
次要结局
- Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population(Baseline to Week 4)
- Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population(Baseline to Week 12)
- Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population(Baseline to Week 4)
- Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population(Baseline to Week 8)
- Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population(Baseline to Week 12)