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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:
ClinicalTrials.gov Identifier:
NCT01133548
First Posted: May 31, 2010
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  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
Intervention Model: Crossover Assignment
Masking: None (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 AbbVie:

Primary Outcome Measures:
  • Maximum Plasma Concentration observed (Cmax) [ Time Frame: Up to 24 days ]
    Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol

  • Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: Up to 24 days ]
    Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol

  • Time of Cmax (Tmax) [ Time Frame: Up to 24 days ]
    Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol

  • Average Plasma Concentration observed (Cav) [ Time Frame: Up to 24 days ]
    Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol


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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133548


Sponsors and Collaborators
AbbVie
Investigators
Study Director: Michael miller, PharmD Abbott
  More Information

Publications:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01133548     History of Changes
Other Study ID Numbers: S176.1.010
First Submitted: May 21, 2010
First Posted: May 31, 2010
Last Update Posted: December 7, 2017
Last Verified: June 2011

Keywords provided by AbbVie:
testosterone, hypogonadal, males

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