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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998933
• Other study ID #: S176.1.009
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2009
• Last updated: November 24, 2009
• Start date: October 2009
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone gel 1.62%
5 grams applied topically to upper arms/shoulder and abdomen on Day 1

Locations

Country	Name	City	State
United States	Site 1	Miami Gardens	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax		4 days	No