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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649896 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Mylan Estradiol Transdermal System 0.025 mg/day Drug: Climara® Transdermal System 0.025 mg/day |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety Study |
| 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 |
| Enrollment: | 76 |
| Study Start Date: | August 2003 |
| Study Completion Date: | September 2003 |
| Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Mylan Estradiol Transdermal System 0.025 mg/day
|
Drug: Mylan Estradiol Transdermal System 0.025 mg/day |
|
2: Active Comparator
Climara® Transdermal System 0.025 mg/day
|
Drug: Climara® Transdermal System 0.025 mg/day |
Eligibility| Ages Eligible for Study: | 40 Years to 69 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | 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.
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
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:
a. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). b. 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.
Contacts and Locations
More Information
| Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | ESTR-0334 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649896 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Estrogens Benzoates Contraceptive Agents Hormone Antagonists Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists |
Adhesions Healthy Estradiol 17 beta-cypionate Hormones Estradiol Estradiol 3-benzoate Polyestradiol phosphate |
|
Estrogens Contraceptive Agents Estradiol valerate Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Estradiol 17 beta-cypionate |
Reproductive Control Agents Hormones Estradiol Pharmacologic Actions Estradiol 3-benzoate Therapeutic Uses Polyestradiol phosphate |