Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch

Official Title: “An Open-label, Multiple-dose, Randomized, Two-period Crossover Study to Assess Bioequivalence of the 300 Mcg/Day Testosterone Reduced-size Patch (14 cm2) Relative to the 300 Mcg/Day Testosterone Reference Patch (28 cm2)”

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 for surgically postmenopausal women or a continuous regimen of estrogen plus progestin for naturally postmenopausal women) restricted to approved oral or transdermal regimens only, or not on concomitant hormone therapy.

Intervention(s) in this Clinical Trial

• Drug: testosterone
  • 28 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
• Drug: testosterone
  • 14 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 28 cm2 testosterone patch
• Experimental: 2
  • 14 cm2 testosterone patch

Primary Measures

• Bioequivalence of two testosterone patches based on baseline-corrected (AUCτ) and baseline-corrected maximum serum concentrations of total testosterone and free testosterone at steady-state
  • Time Frame: 12 days
    Safety Issue?: No

Inclusion Criteria:

• 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 Criteria:

• 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;

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Angela X Qu, MD, MS Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00791856

Study ID Number: 2007016

ClinicalTrials.gov Identifier: NCT00791856

Health Authority: United States: Food and Drug Administration