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OpenTrials
Completed

NCT Number: NCT01130298

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

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone gel 1.62%

Drug

5 grams

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 26, 2010
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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