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

October 2, 2012 updated by: Watson Pharmaceuticals

An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men

The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miramar, Florida, United States, 33025
        • Watson Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68184
        • Watson Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78209
        • Watson Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Testosterone Transdermal Systems
Testosterone
Drug: Testerone Transdermal System
Transdermal testosterone applied daily for 4 weeks
Other Names:
  • Testosterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 28/29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Keshava Kumar, PhD, MHSA, Watson Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

October 5, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AND1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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