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| Sponsor: | 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: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) |
| 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 |
|---|---|
|
Experimental: 1
Mylan Estradiol Transdermal System 0.025 mg/day
|
Drug: Mylan Estradiol Transdermal System 0.025 mg/day |
|
Active Comparator: 2
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:
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:
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:
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:
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: | Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00649896 History of Changes |
| Other Study ID Numbers: | ESTR-0334 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |