NCT00650442已完成1 期
Evaluation of the Adhesion Quality and Primary Dermal Irritation Potential of an Alternate Second Generation Estradiol Transdermal Systems in Normal Healthy Female Volunteers
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
- 39
- 试验地点
- 1
- 主要终点
- Transdermal Adhesion
研究概览
简要总结
The primary objective of this study was to compare the adhesive quality of the current Mylan estradiol placebo transdermal system, with that of an alternate second generation Mylan estradiol placebo transdermal system following a single system application. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 66 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 40-66 years.
- •Sex: Females only.
- •Weight: At least 52 kg (115 lbs) and within 20% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DERMAL SAFETY STUDY PROTOCOLS).
- •All subjects should be judged normal and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation and 12-lead ECG) performed within 14 days of the initial patch application.
排除标准
- •Institutionalized subjects will not be used.
- •Any prior history of skin diseases (eczema, psoriasis, atopic dermatitis).
- •Damaged skin in or around test sites that include sunburn, uneven skin tones, tattoos, scars or other disfigurations of the test site.
- •Abnormal and clinically significant laboratory test results:
- •Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DERMAL SAFETY STUDY PROTOCOLS).
- •Abnormal and clinically relevant ECG tracing.
- •Subjects who have received an investigational drug within 30 days prior to the initial patch application and/or participated in any transdermal system test for irritation or sensitization within the last 4 weeks.
- •Allergy or hypersensitivity to any tapes or adhesives (ex. band-aids, medical tape).
研究组 & 干预措施
1
Experimental
Estradiol Transdermal System Placebo - Alternate Adhesive
干预措施: Estradiol Transdermal System Placebo - Alternate Adhesive (Drug)
2
Placebo Comparator
Estradiol Transdermal System Placebo - Current Adhesive
干预措施: Estradiol Transdermal System Placebo - Current Adhesive (Drug)
结局指标
主要结局
Transdermal Adhesion
时间窗: within 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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