An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men

NCT02082197 | Withdrawn Phase 3

• 1 other identifier: M13-886
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 42

Brief Summary

This is an open-study with a 26 week open label treatment period followed by an optional 26 week open label extension. The total treatment period will be 52 weeks.

Conditions

Hypogonadism; Testosterone Deficiency

Keywords

low testosterone

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with serum total testosterone average concentration, Cavg(0-24)

  Cavg (0-24) is the time-averaged Concentration Over the Dosing Interval of 24 Hours.

  At Week 12

Secondary Outcomes (2)

• Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax)

  At Week 2, Week 4, Week 12 and Week 52

• Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg)

  At Week 2, Week 4, Week 12 and Week 52

Study Arms (1)

ABT-SLV176

EXPERIMENTAL

ABT-SLV176 administered daily

Drug: ABT-SLV176

Interventions

ABT-SLV176 DRUG

ABT-SLV176 administered daily

ABT-SLV176

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 testosterone

You may not qualify if:

• Normal testosterone levels
• Elevated Prostatic Specific Antigen (PSA)
• History of breast or prostate cancer

Sponsors & Collaborators

• AbbVie: lead

Study Sites (42)

Site Reference ID/Investigator# 124163

Birmingham, Alabama, 35213, United States

Location

Site Reference ID/Investigator# 123938

Huntsville, Alabama, 35801, United States

Location

Site Reference ID/Investigator# 125782

Mesa, Arizona, 85202, United States

Location

Site Reference ID/Investigator# 124157

Phoenix, Arizona, 85032, United States

Location

Site Reference ID/Investigator# 123937

Tucson, Arizona, 85712, United States

Location

Site Reference ID/Investigator# 123948

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 124164

Los Angeles, California, 90069, United States

Location

Site Reference ID/Investigator# 123920

Los Gatos, California, 95032, United States

Location

Site Reference ID/Investigator# 124038

Colorado Springs, Colorado, 80907-0000, United States

Location

Site Reference ID/Investigator# 126202

Denver, Colorado, 80218, United States

Location

Site Reference ID/Investigator# 123927

Middlebury, Connecticut, 06762-1835, United States

Location

Site Reference ID/Investigator# 123947

Clearwater, Florida, 33756, United States

Location

Site Reference ID/Investigator# 123929

Jacksonville, Florida, 32216, United States

Location

Site Reference ID/Investigator# 123940

Ocala, Florida, 34471, United States

Location

Site Reference ID/Investigator# 124166

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 123945

Ponte Vedra Beach, Florida, 32081, United States

Location

Site Reference ID/Investigator# 123930

Dunwoody, Georgia, 30338, United States

Location

Site Reference ID/Investigator# 124395

Wichita, Kansas, 67226, United States

Location

Site Reference ID/Investigator# 125784

Crestview Hills, Kentucky, 41017, United States

Location

Site Reference ID/Investigator# 123919

Lexington, Kentucky, 40509, United States

Location

Site Reference ID/Investigator# 123925

Baltimore, Maryland, 21287, United States

Location

Site Reference ID/Investigator# 123936

Methuen, Massachusetts, 01844, United States

Location

Site Reference ID/Investigator# 124160

Las Vegas, Nevada, 89121, United States

Location

Site Reference ID/Investigator# 123939

Las Vegas, Nevada, 89148, United States

Location

Site Reference ID/Investigator# 123932

Lawrenceville, New Jersey, 08648, United States

Location

Site Reference ID/Investigator# 123943

Albuquerque, New Mexico, 87106, United States

Location

Site Reference ID/Investigator# 123926

Garden City, New York, 11530, United States

Location

Site Reference ID/Investigator# 125783

New York, New York, 10016, United States

Location

Site Reference ID/Investigator# 123928

Poughkeepsie, New York, 12601, United States

Location

Site Reference ID/Investigator# 124165

Charlotte, North Carolina, 28209, United States

Location

Site Reference ID/Investigator# 123933

Morehead City, North Carolina, 28557, United States

Location

Site Reference ID/Investigator# 123921

Salisbury, North Carolina, 28144, United States

Location

Site Reference ID/Investigator# 124162

Cleveland, Ohio, 44122, United States

Location

Site Reference ID/Investigator# 123917

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Site Reference ID/Investigator# 123931

Jenkintown, Pennsylvania, 19046, United States

Location

Site Reference ID/Investigator# 123924

Greer, South Carolina, 29651, United States

Location

Site Reference ID/Investigator# 123895

Chattanooga, Tennessee, 37411, United States

Location

Site Reference ID/Investigator# 123946

Nashville, Tennessee, 37203, United States

Location

Site Reference ID/Investigator# 123923

Austin, Texas, 78705-2660, United States

Location

Site Reference ID/Investigator# 123922

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 124167

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 123944

San Antonio, Texas, 78218, United States

Location

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Michael Miller, PharmD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

US (42)