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Testosterone Treatment for Hypogonadal Men

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00433199
First received: February 8, 2007
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Hypogonadism
 Drug: Testosterone (T) Gel 1.62%
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • 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 [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
    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:
  • 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 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 182 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. [ Time Frame: Day 266 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 364 ] [ Designated as safety issue: No ]
    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%.


Enrollment: 274
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo Control
Experimental: T-Gel 1.62%
Testosterone (T) gel 1.62%
 Drug: Testosterone (T) Gel 1.62%
Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low T males 18 - 80 years of age

Exclusion Criteria:

  • Normal T levels
  • Elevated Prostatic Specific Antigen (PSA)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433199

Sponsors and Collaborators
Abbott Products
Investigators
Study Director: Global Clinical Director Solvay Abbott Products
  More Information

No publications provided by Solvay Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Miller, Pharm. D Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00433199     History of Changes
Other Study ID Numbers: S176.3.104
Study First Received: February 8, 2007
Results First Received: May 27, 2011
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Hypogonadism
Testosterone Deficiency

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on June 17, 2013