Testosterone Treatment for Hypogonadal Men

Hypogonadism Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433199
• Other study ID #: S176.3.104
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2007
• Last updated: January 15, 2015
• Start date: February 2007
• Est. completion date: April 2008

Study information

• Verified date: November 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: April 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Low T males 18 - 80 years of age

Exclusion Criteria:

• Normal T levels

• Elevated Prostatic Specific Antigen (PSA)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone (T) Gel 1.62%
Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.
• Placebo
Placebo Control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Day 112	No
Secondary	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	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	Day 14	No
Secondary	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	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	Day 56	No
Secondary	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	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.	Day 182	No
Secondary	Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at 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%.	Day 266	No
Secondary	Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at 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%.	Day 364	No