Back to resultsDose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
Primary Purpose
Hypogonadism
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Testerone Transdermal System
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring Hypogonadism, Testosterone, Hormone replacement therapy
Eligibility 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.
Sites / Locations
- Watson investigational site
- Watson investigational site
- Watson investigational site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Testosterone Transdermal Systems
Arm Description
Testosterone
Outcomes
Primary Outcome Measures
Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01104246
Brief Title
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
Official Title
An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Hypogonadism, Testosterone, Hormone replacement therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testosterone Transdermal Systems
Arm Type
Experimental
Arm Description
Testosterone
Intervention Type
Drug
Intervention Name(s)
Testerone Transdermal System
Other Intervention Name(s)
Testosterone
Intervention Description
Transdermal testosterone applied daily for 4 weeks
Primary Outcome Measure Information:
Title
Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
Description
A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.
Time Frame
Day 28/29
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keshava Kumar, PhD, MHSA
Organizational Affiliation
Watson Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Watson investigational site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Watson investigational site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68184
Country
United States
Facility Name
Watson investigational site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
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