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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00649896 |
Recruitment Status :
Completed
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Mylan Estradiol Transdermal System 0.025 mg/day Drug: Climara® Transdermal System 0.025 mg/day | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (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 |
Study Start Date : | August 2003 |
Actual Primary Completion Date : | September 2003 |
Actual Study Completion Date : | September 2003 |

Arm | Intervention/treatment |
---|---|
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 |
- Dermal Safety [ Time Frame: within 30 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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):
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:
- 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.
7. Allergy or hypersensitivity to tapes or adhesives (ex. Band-aids, medical tape), estradiol or other hormonal products.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649896
United States, Florida | |
SFBC International | |
Miami, Florida, United States, 33181 |
Principal Investigator: | Lawrence A Galitz, M.D. | SFBC International |
Responsible Party: | Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc. |
ClinicalTrials.gov Identifier: | NCT00649896 |
Other Study ID Numbers: |
ESTR-0334 |
First Posted: | April 1, 2008 Key Record Dates |
Last Update Posted: | April 1, 2008 |
Last Verified: | March 2008 |
Tissue Adhesions Cicatrix Fibrosis Pathologic Processes Estradiol |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |