Testosterone Treatment for Hypogonadal Men

NCT00433199 | Completed Phase 3 Results

• 1 other identifier: S176.3.104
• Study Type: interventional
• Target: 274
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypogonadism

Keywords

Hypogonadism; Testosterone Deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• 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

• 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

• Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.

  Day 266

• Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.

  Day 364

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

T-Gel 1.62%

EXPERIMENTAL

Testosterone (T) gel 1.62%

Drug: Testosterone (T) Gel 1.62%

Interventions

Testosterone (T) Gel 1.62% DRUG

Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.

T-Gel 1.62%

Placebo DRUG

Placebo Control

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low T males 18 - 80 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Abbott: lead

Related Publications (1)

• Kaufman JM, Miller MG, Fitzpatrick S, McWhirter C, Brennan JJ. One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: results of a 182-day open-label extension of a 6-month double-blind study. J Sex Med. 2012 Apr;9(4):1149-61. doi: 10.1111/j.1743-6109.2011.02630.x. Epub 2012 Feb 9.

  PMID: 22321357 DERIVED

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-91110

Study Officials

• Global Clinical Director Solvay

  Abbott Products

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 9, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: April 1, 2008
• Last Updated: January 27, 2015
• Results First Posted: December 8, 2011

Record last verified: 2011-11