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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00791856
First received: November 14, 2008
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: testosterone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
28 cm2 testosterone patch
Drug: testosterone
28 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
Experimental: 2
14 cm2 testosterone patch
Drug: testosterone
14 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791856

Locations
United States, Florida
Antonio Pizarro, MD
Fort Myers, Florida, United States, 33901
Maria J Gulierrez, MD
Miramar, Florida, United States, 33025
United States, Kansas
David R Mathews, MD
Overland Park, Kansas, United States, 66211
United States, Nebraska
Robert J Schwab, MD
Omaha, Nebraska, United States, 68154
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Angela X Qu, MD, MS Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00791856     History of Changes
Other Study ID Numbers: 2007016
Study First Received: November 14, 2008
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on July 23, 2014