CClinicalTrials.gg
CompletedNCT01130298Updated Dec 7, 2017

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

A Phase 1 interventional study of Testosterone Gel 1.62% in Healthy, sponsored by AbbVie. Completed. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by AbbVie · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • testosterone,
  • Pharmacokinetics
  • replacement,
  • therapy
03

In context

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI between 20-35 kg/m\^2 inclusive.

Exclusion criteria

Exclusion Criteria

  • Males: history, current or suspected prostate or breast cancer.
  • Females: pregnant or lactating.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    1

    Drug: Testosterone Gel 1.62%

Interventions

  • DrugTestosterone Gel 1.62%

    5 grams

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration observed (Cmax)

    Maximum plasma concentration observed (Cmax) of total testosterone

    Time frame: Up to 5 days

  2. Area Under the Plasma Concentration-time Curve (AUC)

    Area under the plasma concentration-time curve (AUC) of total testosterone

    Time frame: Up to 5 days

  3. Average Plasma Concentration observed (Cav)

    Average Plasma Concentration observed (Cav) of total testosterone

    Time frame: Up to 5 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 22188558 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01130298
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
May 26, 2010
Start date
May 2010
Primary completion
May 2010
Completion
May 2010
Last update
Dec 7, 2017

Study contacts

Michael Miller, PharmD
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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