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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:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01130298
First received: May 21, 2010
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax [ Time Frame: 5 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Abbott

Additional 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
Study First Received: May 21, 2010
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 23, 2013