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Testosterone Treatment for Hypogonadal Men

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ClinicalTrials.gov Identifier: NCT00433199
Recruitment Status : Completed
First Posted : February 9, 2007
Results First Posted : December 8, 2011
Last Update Posted : January 27, 2015
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone (T) Gel 1.62% Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : February 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : April 2008

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 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 :
  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 14 [ Time Frame: 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

  2. 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 ]
    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

  3. 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 ]
    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.

  4. Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. [ Time Frame: 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%.

  5. Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364. [ Time Frame: 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%.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433199


Sponsors and Collaborators
Abbott
Investigators
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Study Director: Global Clinical Director Solvay Abbott Products
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Miller, Pharm. D Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00433199    
Other Study ID Numbers: S176.3.104
First Posted: February 9, 2007    Key Record Dates
Results First Posted: December 8, 2011
Last Update Posted: January 27, 2015
Last Verified: November 2011
Keywords provided by Abbott:
Hypogonadism
Testosterone Deficiency
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
 Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs