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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650442 |
The primary objective of this study was to compare the adhesive quality of the current Mylan estradiol placebo transdermal system, with that of an alternate second generation Mylan estradiol placebo transdermal system following a single system application. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Estradiol Transdermal System Placebo - Alternate Adhesive Drug: Estradiol Transdermal System Placebo - Current Adhesive |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Safety Study |
Official Title: | Evaluation of the Adhesion Quality and Primary Dermal Irritation Potential of an Alternate Second Generation Estradiol Transdermal Systems in Normal Healthy Female Volunteers |
Enrollment: | 39 |
Study Start Date: | January 2003 |
Study Completion Date: | February 2003 |
Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Estradiol Transdermal System Placebo - Alternate Adhesive
|
Drug: Estradiol Transdermal System Placebo - Alternate Adhesive
single application
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2: Placebo Comparator
Estradiol Transdermal System Placebo - Current Adhesive
|
Drug: Estradiol Transdermal System Placebo - Current Adhesive
single application
|
Ages Eligible for Study: | 40 Years to 66 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Abnormal and clinically significant laboratory test results:
United States, West Virginia | |
Kendle International Inc. | |
Morgantown, West Virginia, United States, 26505 |
Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | ESTR-02133 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650442 |
Health Authority: | United States: Institutional Review Board |
Benzoates Estradiol 3-benzoate Estradiol valerate Adhesions |
Estradiol 17 beta-cypionate Healthy Polyestradiol phosphate Estradiol |
Estrogens Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs Contraceptive Agents, Female |
Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions |