NCT00998933

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

Same day

First QC Date

October 20, 2009

Last Update Submit

November 24, 2009

Conditions

Hypogonadism

Keywords

Testosterone replacement therapy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax

    4 days

Study Arms (1)

1

EXPERIMENTAL
Drug: Testosterone gel 1.62%

Interventions

Testosterone gel 1.62%DRUG

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

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 1

Miami Gardens, Florida, United States

Location

Related Publications (1)

  • 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.

    PMID: 22188558DERIVED

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

US(1)