Testosterone Treatment for Hypogonadal Men

Phase 3

Completed

• Conditions: Hypogonadism
• Interventions: Drug: Placebo; Drug: Testosterone (T) Gel 1.62%

• Registration Number: NCT00433199
• Lead Sponsor: Abbott

Brief Summary

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-08
• Study First Submitted QC: 2007-02-08
• Study First Posted: 2007-02-09
• Primary Completion: 2007-10
• Study Completion: 2008-04
• Results First Submitted: 2011-05-27
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-03
• Results First Posted: 2011-12-08
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 274

Inclusion Criteria

• Low T males 18 - 80 years of age

Exclusion Criteria

• Normal T levels
• Elevated Prostatic Specific Antigen (PSA)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
T-Gel 1.62%	Testosterone (T) Gel 1.62%	Testosterone (T) gel 1.62%

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112	Day 112	Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as \>=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.	Day 266	The success at Day 266 was defined as \>=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.	Day 364	The success at Day 364 was defined as \>=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14	Day 14	Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as \>=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56	Day 56	Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as \>=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182	Day 182	Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as \>=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.