Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara® Transdermal System 0.025 mg/Day
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33181
- SFBC International
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Diseases:
- History of any significant chronic disease such as (but not limited to):
1. Thrombotic disorders. 2. Coronary artery or cerebrovascular disease. 3. Liver, kidney or gallbladder dysfunction/disorder(s). 4. Fibrocystic disease or breast nodules. 5. Family history of breast cancer. 6. Diabetes or any other endocrinological disease. 7. Estrogen-dependent neoplasia. 8. Postmenopausal uterine bleeding. 9. Endometrial hyperplasia. b. History of drug and/or alcohol abuse. c. Acute illness at the time of either the prestudy medical evaluation or dosing.
5. 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. 6. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
7. Allergy or hypersensitivity to tapes or adhesives (ex. Band-aids, medical tape), estradiol or other hormonal products.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Mylan Estradiol Transdermal System 0.025 mg/day
|
|
|
Active Comparator: 2
Climara® Transdermal System 0.025 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Dermal Safety
Time Frame: within 30 days
|
within 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lawrence A Galitz, M.D., SFBC International
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESTR-0334
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