NCT00649896已完成1 期
Comparative Evaluation of the Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System (0.025 mg/Day; Mylan) and Climara® Transdermal System (0.025 mg/Day; Berlex) in Healthy Postmenopausal 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
- 76
- 试验地点
- 1
- 主要终点
- Dermal Safety
研究概览
简要总结
The primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following a single system application in 80 healthy postmenopausal female volunteers. 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
- Single Group
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 40-69 years.
- •Sex: Females only.
- •Weight: At least 52 kg (115 lbs) and within 30% 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 BIOAVAILABILITY PROTOCOLS).
- •Absence of menses for one year for postmenopausal subjects, or at least 6 weeks for oophorectomized subjects. (For oophorectomized subjects, an operative report documenting bilateral oophorectomy and surgical pathology report documenting the absence of malignant disease.)
- •Baseline FSH and 17-beta-estradiol serum levels consistent with postmenopausal status confirmed within 14 days of initiation of study medication. (FSH greater than or equal to 40 mIU/mL; 17-beta-estradiol less than or equal to 31 pg/mL)
- •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.
- •The physical examination shall include pelvic and breast exams.
- •a. Pelvic findings should be consistent with hypoestrogenemia. b. A mammogram will be required if not performed within the last 12 months. c. A Papanicolaou ("Pap") smear will be required on subjects with an intact uterus and cervix if not performed within the last 6 months.
排除标准
- •Institutionalized subjects will not be used.
- •Social Habits:
- •a. Use of any tobacco products. b. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- •c. Ingestion of any vitamins within the 48 hours prior to the initial dose of study medication.
- •d. Any recent, significant change in dietary or exercise habits.
- •Medications:
- •Use of any medication within 14 days prior to the initial dose of study medication.
- •Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- •Use of any systemic antibiotics, estrogens, or hormones within 28 days prior to the initial dose of study medication.
- •History of any significant chronic disease such as (but not limited to):
- •Thrombotic disorders.
- •Coronary artery or cerebrovascular disease.
- •Liver, kidney or gallbladder dysfunction/disorder(s).
- •Fibrocystic disease or breast nodules.
- •Family history of breast cancer.
- •Diabetes or any other endocrinological disease.
- •Estrogen-dependent neoplasia.
- •Postmenopausal uterine bleeding.
- •Endometrial hyperplasia. b. History of drug and/or alcohol abuse. c. Acute illness at the time of either the prestudy medical evaluation or dosing.
- •Abnormal and clinically significant laboratory test results:
- •Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- •Abnormal and clinically relevant ECG tracing.
- •Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- •Allergy or hypersensitivity to tapes or adhesives (ex. Band-aids, medical tape), estradiol or other hormonal products.
研究组 & 干预措施
1
Experimental
Mylan Estradiol Transdermal System 0.025 mg/day
干预措施: Mylan Estradiol Transdermal System 0.025 mg/day (Drug)
2
Active Comparator
Climara® Transdermal System 0.025 mg/day
干预措施: Climara® Transdermal System 0.025 mg/day (Drug)
结局指标
主要结局
Dermal Safety
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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