Pharmacokinetic Evaluation of Testosterone Gel (1%)

Phase 1

Completed

• Conditions: Primary or Secondary Hypogonadism; Constitutional Delay in Growth and Puberty (CDGP)

• Registration Number: NCT00193700
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel. Subjects who complete this trial may participate in the extension part (UMD-01-080E).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-19
• Status Verified: 2006-11
• Last Update Submitted: 2006-12-23
• Last Update Posted: 2006-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion Criteria

• Clinically significant uncontrolled medical condition or psychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (9)

Site 209; 🇺🇸 Cincinnati, Ohio, United States

Site 205; 🇺🇸 Seattle, Washington, United States

Site 207; 🇺🇸 Brooklyn, New York, United States

Site 202; 🇺🇸 Philadelphia, Pennsylvania, United States

Site 201; 🇺🇸 Kansas City, Missouri, United States

Site 203; 🇺🇸 Torrance, California, United States

Site 208; 🇺🇸 Birmingham, Alabama, United States

Site 204; 🇺🇸 Jacksonville, Florida, United States

Site 206; 🇺🇸 Morristown, New Jersey, United States