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

Primary Purpose

Hypogonadism

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Testosterone gel 1.62%

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Testosterone replacement therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Site 1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax

Secondary Outcome Measures

Full Information

NCT ID

NCT00998933

First Posted

October 20, 2009

Last Updated

November 24, 2009

Sponsor

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00998933

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism

Keywords

Testosterone replacement therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Testosterone gel 1.62%

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax

Time Frame

4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Director Solvay

Organizational Affiliation

Solvay Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Site 1

City

Miami Gardens

State/Province

Florida

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22188558

Citation

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.

Results Reference

derived

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

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