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

NCT00649896 | Completed Phase 1

• 1 other identifier: ESTR-0334
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Dermal Safety

  within 30 days

Study Arms (2)

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

Interventions

Mylan Estradiol Transdermal System 0.025 mg/day DRUG

1

Climara® Transdermal System 0.025 mg/day DRUG

2

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

SFBC International

Miami, Florida, 33181, United States

Location

Related Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

Study Officials

• Lawrence A Galitz, M.D.

  SFBC International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 1, 2008
• Study Start: August 1, 2003
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: April 1, 2008

Record last verified: 2008-03

Locations

US (1)