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
Information source: Mylan Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Mylan Estradiol Transdermal System 0.025 mg/day (Drug); Climara® Transdermal System 0.025 mg/day (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s):
Lawrence A Galitz, M.D., Principal Investigator, Affiliation: SFBC International
Summary
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.
Clinical Details
Official title: 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 design: Other, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety Study
Primary outcome: Dermal Safety
Eligibility
Minimum age: 40 Years.
Maximum age: 69 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Age: 40-69 years.
2. Sex: Females only.
3. 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).
4. 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.)
5. 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)
6. 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.
7. 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:
1. Institutionalized subjects will not be used.
2. 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.
3. Medications:
1. Use of any medication within 14 days prior to the initial dose of study
medication.
2. Use of any medication known to alter hepatic enzyme activity within 28 days prior
to the initial dose of study medication.
3. Use of any systemic antibiotics, estrogens, or hormones within 28 days prior to
the initial dose of study medication.
4. Diseases:
1. 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:
1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities
(See Part II: ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
2. 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.
Locations and Contacts
SFBC International, Miami, Florida 33181, United States
Additional Information
Mylan Pharmaceuticals Inc. - Clinical Trial Results Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use Recalls, Market Withdrawals and Safety Alerts FDA Enforcement Report Index Medwatch, FDA Safety Information and Adverse Event Reporting Program
Starting date: August 2003
Ending date: September 2003
Last updated: March 31, 2008
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