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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00998933

Enrollment

Registered

2009-10-21

Start date

2009-10-31

Completion date

2009-10-31

Last updated

2009-11-25

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

Conditions

Hypogonadism

Keywords

Testosterone replacement therapy

Brief summary

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

Interventions

DRUGTestosterone gel 1.62%

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax	4 days

Countries

United States

Outcome results

None listed

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