Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01133548
First received: May 21, 2010
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.


Condition Intervention Phase
Hypogonadism
Drug: Testosterone Gel 1.62%
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multiple Dose Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of 5 g Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pharmacokinetic Parameters Total Testosterone, dihydrotestosterone, estradiol AUC, Cav, Cmax, Tmax [ Time Frame: 24 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Application site evaluation based on the clinical evaluation of skin reactions grading scale [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Testosterone Gel 1.62%
Drug: Testosterone Gel 1.62%
5 grams administered using an application Site Rotation
Drug: Testosterone Gel 1.62%
5 grams administered using an a combination of Application sites

Detailed Description:

To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Hypogonadal males
  2. Screening testosterone <300 ng/dL

Exclusion Criteria

  1. Smokers
  2. Previous history of or current or suspected prostate or breast cancer
  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: NCT01133548

Locations
United States, Florida
Site Reference ID/Investigator# 57442
Fort Myers, Florida, United States, 33901-0000
Sponsors and Collaborators
Abbott
Investigators
Study Director: Michael miller, PharmD Abbott
  More Information

No publications provided

Responsible Party: Michael Miller, Project Director, Abbott
ClinicalTrials.gov Identifier: NCT01133548     History of Changes
Other Study ID Numbers: S176.1.010
Study First Received: May 21, 2010
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
testosterone, hypogonadal, males

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 22, 2014