Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men
1 other identifier
interventional
40
1 country
3
Brief Summary
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2010
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
February 23, 2011
CompletedOctober 5, 2012
October 1, 2012
5 months
April 13, 2010
February 1, 2011
October 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 28/29
Study Arms (1)
Testosterone Transdermal Systems
EXPERIMENTALTestosterone
Interventions
Transdermal testosterone applied daily for 4 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Watson investigational site
Miramar, Florida, 33025, United States
Watson investigational site
Omaha, Nebraska, 68184, United States
Watson investigational site
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
- Organization
- Watson Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
Keshava Kumar, PhD, MHSA
Watson Laboratories
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2010
First Posted
April 15, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
October 5, 2012
Results First Posted
February 23, 2011
Record last verified: 2012-10