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Testosterone Treatment for Hypogonadal Men

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: Testosterone (T) Gel 1.62% (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Abbott Products

Summary

Demonstrate efficacy and safety of Testosterone Gel 1. 62% for the treatment of hypogonadal men

Clinical Details

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

Primary outcome: 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

Secondary outcome:

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

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

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Low T males 18 - 80 years of age

Exclusion Criteria:

- Normal T levels

- Elevated Prostatic Specific Antigen (PSA)

Locations and Contacts

Additional Information

Starting date: February 2007
Last updated: January 15, 2015

Page last updated: August 23, 2015

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