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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01104246
First received: April 13, 2010
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Hypogonadism
Drug: Testerone Transdermal System
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours [ Time Frame: Day 28/29 ] [ Designated as safety issue: No ]
    A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.


Enrollment: 40
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosterone Transdermal Systems
Testosterone
Drug: Testerone Transdermal System
Transdermal testosterone applied daily for 4 weeks
Other Name: Testosterone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104246

Locations
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
Study Director: Keshava Kumar, PhD, MHSA Watson Laboratories
  More Information

No publications provided

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01104246     History of Changes
Other Study ID Numbers: AND1001
Study First Received: April 13, 2010
Results First Received: February 1, 2011
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
Hypogonadism
Testosterone
Hormone replacement therapy

Additional relevant MeSH terms:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014