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

To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 1

Miami Gardens, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females).

Exclusion criteria

Males: history, current or suspected prostate or breast cancer.
Female: pregnant or lactating.

Treatment and study plan

Testosterone gel 1.62%

Drug

5 grams applied topically to upper arms/shoulder and abdomen on Day 1

Primary outcomes

Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax

Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study title

An Open-label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62%

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Oct 21, 2009
Registry last updated: Nov 25, 2009

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.

Published trials that share one or more normalized conditions with this study.

Completed