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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01130298

Enrollment

Registered

2010-05-26

Start date

2010-05-31

Completion date

2010-05-31

Last updated

2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

testosterone,, Pharmacokinetics, replacement,, therapy

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.

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.

Interventions

DRUGTestosterone Gel 1.62%

5 grams

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Plasma Concentration observed (Cmax)	Up to 5 days	Maximum plasma concentration observed (Cmax) of total testosterone
Area Under the Plasma Concentration-time Curve (AUC)	Up to 5 days	Area under the plasma concentration-time curve (AUC) of total testosterone
Average Plasma Concentration observed (Cav)	Up to 5 days	Average Plasma Concentration observed (Cav) of total testosterone

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026