We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01130298
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Testosterone Gel 1.62% Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : May 2010
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Testosterone Gel 1.62%
5 grams



Primary Outcome Measures :
  1. Maximum Plasma Concentration observed (Cmax) [ Time Frame: Up to 5 days ]
    Maximum plasma concentration observed (Cmax) of total testosterone

  2. Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: Up to 5 days ]
    Area under the plasma concentration-time curve (AUC) of total testosterone

  3. Average Plasma Concentration observed (Cav) [ Time Frame: Up to 5 days ]
    Average Plasma Concentration observed (Cav) of total testosterone



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:   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.

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


Sponsors and Collaborators
AbbVie
Investigators
Study Director: Michael Miller, PharmD Abbott

Publications:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01130298     History of Changes
Other Study ID Numbers: S176.1.011
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: June 2011

Keywords provided by AbbVie:
testosterone,
Pharmacokinetics
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