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

December 5, 2017 updated by: AbbVie

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.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Drug: Testosterone Gel 1.62%

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

Enrollment (Actual)

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Testosterone Gel 1.62% 5 grams

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration observed (Cmax) Time Frame: Up to 5 days	Maximum plasma concentration observed (Cmax) of total testosterone	Up to 5 days
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	Up to 5 days
Average Plasma Concentration observed (Cav) Time Frame: Up to 5 days	Average Plasma Concentration observed (Cav) of total testosterone	Up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

S176.1.011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

University of Vermont Medical Center
Avocado Nutrition Center

Recruiting

Avocado and Postprandial Responses

Healthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokers

United States
Dragonfly Therapeutics

Recruiting

A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults (DF5112)

Healthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult Male

Australia
University of Palermo

Completed

Neck Static Stretching Acutely Reduces Blood Pressure Through Reduction of Tissue Stiffness

Healthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | Stretching

Italy
Prevent Age Resort "Pervaya Liniya"

Recruiting

First Line Prevent Age Study (FLIPS)

Healthy Aging | Healthy Diet | Healthy Lifestyle

Russian Federation
Yale University

Not yet recruiting

Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health

Healthy Diet | Healthy Lifestyle | Healthy Nutrition | Cholesterol

United States
Umm Al-Qura University

Active, not recruiting

Effect of Magnesium Supplementation on Sleep Quality and Cognitive Function in Saudi Adults

Healthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult Subjects

Saudi Arabia
Maastricht University Medical Center

Completed

Reference Gait Data for Healthy Subjects

Healthy Volunteers | Healthy Subjects | Healthy Adults

Netherlands
University of Palermo

Completed

Roller Massage and Blood Pressure

Healthy Participants | Healthy Adult Participants | Healthy Young Adults

Italy
Pfizer

Not yet recruiting

A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults

Healthy | Healthy Adults

United States
RAGE Bio

Recruiting

Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers

Healthy | Healthy Smoker

Australia

Clinical Trials on Testosterone Gel 1.62%

Amneal Pharmaceuticals, LLC
Phase One Solutions, Inc.

Completed

Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions

Hypogonadotropic Hypogonadism | Primary Hypogonadism

United States
Solvay Pharmaceuticals

Completed

Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure

Hypogonadism

United States
University of Washington

Completed

T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin (T-IR)

Obesity | Type 2 Diabetes Mellitus | Insulin Resistance | Metabolic Disease | Androgen Deficiency

United States
AbbVie

Completed

A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

Hypogonadism

United States
Abbott

Completed

Testosterone Treatment for Hypogonadal Men

Hypogonadism
AbbVie

Completed

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

Hypogonadism
Seattle Institute for Biomedical and Clinical Research

Recruiting

Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency (TEMEC)

Cancer | Fatigue | Hypogonadism, Male

United States
Lipocine Inc.
PPD; Syneos Health

Completed

Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism (SOAR)

Male Hypogonadism
VA Office of Research and Development

Completed

Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism

Type 2 Diabetes Mellitus | Hypogonadism

United States
Kessler Foundation
United States Department of Defense

Unknown

TRT in Combination With Electrical Stimulation and Standing: Effect on Muscle and Bone in Spinal Cord Injured Males

Spinal Cord Injury

United States

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 Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on Testosterone Gel 1.62%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations