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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00649896

Run by

Mylan Pharmaceuticals Inc

People needed

76

Starts

2003-08-01

Expected to finish

2003-09-01

Last updated by the study team

2008-04-01

Who can join

Age: 40 and older, up to 69. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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):
• 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.
• 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.
• Allergy or hypersensitivity to tapes or adhesives (ex. Band-aids, medical tape), estradiol or other hormonal products.

Where it is running

• SFBC International — Miami, Florida, United States

Full record on ClinicalTrials.gov

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