NCT00799708已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Effects of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7
研究概览
简要总结
This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is healthy, postmenopausal woman at least 40 years of age with onset of menopause within 10 years of screening
- •Subject has a normal mammogram at screening
- •Subject has had a normal Pap-smear within 3 years of screening. Subjects who have not had a Pap-smear in the last 3 years will have the option to have the test at screening
- •Subject agrees to avoid medications that cause dry mouth or otherwise affect saliva flow
- •Subject is willing to avoid strenuous exercise during the study
- •Subject is willing to avoid use of mouthwash or salt water rinses during the study
- •Subject is willing to avoid use of teeth whitening products
- •Subject is willing to avoid eating and/or drinking grapefruit products
- •Subject is willing to limit alcohol consumption to 2 drinks a day
- •Subject is willing to limit caffeine consumption to 3 cups of coffee (or equivalent) per day
- •Subject is a non-smoker
排除标准
- •Subject has a history of multiple and/or severe allergies to drugs or food
- •Subject has a cold or viral infection within 2 weeks of Visit 2
- •Subject is taking antibiotics within 2 weeks of Visit 2
- •Subject needs dental work or procedures during the study
- •Subject has used any estrogen or progesterone preparation or product containing phytoestrogens within 3 months of screening
- •Subject is unable to discontinue anti-coagulants
研究组 & 干预措施
2
Active Comparator
Estrace 0.5 mg
干预措施: Comparator: Estrace (Drug)
1
Placebo Comparator
Placebo
干预措施: Comparator: placebo (Drug)
3
Active Comparator
Estrace 2 mg
干预措施: Comparator: Estrace (Drug)
结局指标
主要结局
Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7
时间窗: Baseline and Day 7
Subset of genes on the log ratio intensity scale from a microarray platform - signature was pre-specified from an internally conducted study in knock-out mice treated with estrogens- quantified as a ratio of up regulated versus down regulated genes
次要结局
- Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.(Baseline and Day 7)
研究者
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