Status:
COMPLETED
Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch
Lead Sponsor:
Warner Chilcott
Conditions:
Healthy
Eligibility:
FEMALE
20-70 years
Phase:
PHASE1
Brief Summary
This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy (i.e., estrogen ...
Eligibility Criteria
Inclusion
- be a surgically postmenopausal female between 20 and 70 years of age who had a hysterectomy and bilateral oophorectomy at least 6 months prior to screening, or be a healthy naturally postmenopausal female between 50 and 70 years of age who had experienced amenorrhea for at least 12 months prior to screening;
- be in good general health based on medical history, physical examination, and laboratory evaluation;
- have had a mammogram, with no clinically significant abnormalities, within the preceding 12 months in subjects \> 40 years of age;
- be on a stable dose of approved hormone therapy restricted to oral or transdermal regimens (vaginal products are not acceptable) for a period of at least 12 weeks prior to screening:
- estrogen only for surgically postmenopausal women, or
- estrogen only for naturally postmenopausal women who have been hysterectomized, or
- a continuous regimen of estrogen plus progestin for naturally postmenopausal women who have not been hysterectomized
- or not be on any hormone therapy (having stopped hormone therapy at least 12 weeks prior to screening;
Exclusion
- have any uncontrolled acute diseases or had a major surgical operation requiring hospitalization within 1 month of screening;
- have uncontrolled or chronic diseases, such as hypertension (with diastolic blood pressure \> 95 mm Hg on medication), systemic lupus erythematosus, or rheumatoid arthritis;
- have a history of myocardial infarction, bypass surgery, stroke, pulmonary embolism, or deep vein thrombosis;
- have a history of cancer within the last 5 years (except for basal cell carcinoma with a documented 6 month remission), abnormal vaginal bleeding, or tuberculosis;
- have uncontrolled diabetes mellitus with HbA1C \> 7.5% (Note: only subjects who have diabetes mellitus or a fasting serum glucose level at the screening visit above the laboratory's upper limit of normal for the reference range will have HbA1C tested prior to randomization.);
- have any abnormal clinical laboratory values at screening assessed as clinically significant by the Investigator;
- have a serum thyroid stimulating hormone (TSH) value outside the normal laboratory range, confirmed by free T4 levels outside the normal laboratory range;
- have current severe dermatological problems (e.g., severe or cystic acne), including concomitant skin disease or a history of drug-induced contact dermatitis;
- have participated in a cumulative irritation test within the past 12 weeks, or have a known or suspected hypersensitivity or allergy to any transdermal systems including components of the patches used in this study;
- currently use or have a history of any androgen treatment within 6 months prior to screening, or use dehydroepiandrosterone 25 mg per day, or St. John's Wort within 4 weeks prior to baseline. Due to the large number of herbal remedies available, all other herbal supplements will be reviewed by the Sponsor during screening;
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00791856
Start Date
July 1 2007
End Date
May 1 2008
Last Update
April 17 2013
Active Locations (4)
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1
Antonio Pizarro, MD
Fort Myers, Florida, United States, 33901
2
Maria J Gulierrez, MD
Miramar, Florida, United States, 33025
3
David R Mathews, MD
Overland Park, Kansas, United States, 66211
4
Robert J Schwab, MD
Omaha, Nebraska, United States, 68154