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Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

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ClinicalTrials.gov Identifier: NCT01104246
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 23, 2011
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Description
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Brief Summary:
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testerone Transdermal System Phase 1

Detailed Description:
Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men
Study Start Date : April 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Testosterone Transdermal Systems
Testosterone
 Drug: Testerone Transdermal System
Transdermal testosterone applied daily for 4 weeks
Other Name: Testosterone


Outcome Measures
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Primary Outcome Measures :
  1. Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours [ Time Frame: Day 28/29 ]
    A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males in good general health, 18 years of age or older.
  • Have a previously documented testosterone deficiency.
  • Willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

  • Have a history of intolerance to Androderm or other testosterone products.
  • Prostate specific antigen (PSA) level ≥ 4.0 ng/mL
  • Prostate cancer or severe benign prostatic hypertrophy (BPH)
  • Have significant abnormalities in the physical examination at screening.
  • Have current dermatological disease, skin damage or blemishes.
  • Have participated in an investigational drug study within 30 days prior to screening.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01104246


Locations
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United States, Florida
Watson investigational site
Miramar, Florida, United States, 33025
United States, Nebraska
Watson investigational site
Omaha, Nebraska, United States, 68184
United States, Texas
Watson investigational site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Director: Keshava Kumar, PhD, MHSA Watson Laboratories
More Information
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Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01104246    
Other Study ID Numbers: AND1001
First Posted: April 15, 2010    Key Record Dates
Results First Posted: February 23, 2011
Last Update Posted: October 5, 2012
Last Verified: October 2012
Keywords provided by Watson Pharmaceuticals:
Hypogonadism
Testosterone
Hormone replacement therapy
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
 Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs