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”

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.

Study Type: Interventional

Study Design: Other, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety Study

Study Primary Completion Date: September 2003

Intervention(s) in this Clinical Trial

• Drug: Mylan Estradiol Transdermal System 0.025 mg/day
• Drug: Climara® Transdermal System 0.025 mg/day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Mylan Estradiol Transdermal System 0.025 mg/day
• Active Comparator: 2
  • Climara® Transdermal System 0.025 mg/day

Primary Measures

• Dermal Safety
  • Time Frame: within 30 days
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 69 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mylan Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Lawrence A Galitz, M.D. Principal Investigator SFBC International  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00649896

Study ID Number: ESTR-0334

ClinicalTrials.gov Identifier: NCT00649896

Health Authority: United States: Institutional Review Board

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