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

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. Identifier: NCT00791856
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : April 17, 2013
Information provided by (Responsible Party):
Warner Chilcott

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 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 or disease Intervention/treatment Phase
Healthy Drug: testosterone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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)
Study Start Date : July 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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;

Information from the National Library of Medicine

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 identifier (NCT number): NCT00791856

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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
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Study Director: Angela X Qu, MD, MS Procter and Gamble
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Responsible Party: Warner Chilcott Identifier: NCT00791856    
Other Study ID Numbers: 2007016
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents