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An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130298
First Posted: May 26, 2010
Last Update Posted: July 4, 2011
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:
Abbott
  Purpose
Single-center, single dose, open-label study in healthy male and female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax [ Time Frame: 5 days ]

Enrollment: 24
Study Start Date: May 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Testosterone Gel 1.62%
5 grams

Detailed Description:
Single-center, single dose, open-label study in 12 healthy male and 12 healthy female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria BMI between 20-35 kg/m^2 inclusive.

Exclusion Criteria Males: history, current or suspected prostate or breast cancer. Females: pregnant or lactating.

  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): NCT01130298


Locations
United States, Florida
Site Reference ID/Investigator# 58455
Miami Gardens, Florida, United States
Sponsors and Collaborators
Abbott
Investigators
Study Director: Michael Miller, PharmD Abbott
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Miller, Abbott
ClinicalTrials.gov Identifier: NCT01130298     History of Changes
Other Study ID Numbers: S176.1.011
First Submitted: May 21, 2010
First Posted: May 26, 2010
Last Update Posted: July 4, 2011
Last Verified: June 2011

Keywords provided by Abbott:
testosterone, replacement, therapy

Additional relevant MeSH terms:
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