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

May 29, 2014 updated by: AbbVie

A Multicenter, Open-Label, Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Site Reference ID/Investigator# 124163
      • Huntsville, Alabama, United States, 35801
        • Site Reference ID/Investigator# 123938
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Site Reference ID/Investigator# 125782
      • Phoenix, Arizona, United States, 85032
        • Site Reference ID/Investigator# 124157
      • Tucson, Arizona, United States, 85712
        • Site Reference ID/Investigator# 123937
    • California
      • Anaheim, California, United States, 92801
        • Site Reference ID/Investigator# 123948
      • Los Angeles, California, United States, 90069
        • Site Reference ID/Investigator# 124164
      • Los Gatos, California, United States, 95032
        • Site Reference ID/Investigator# 123920
    • Colorado
      • Colorado Springs, Colorado, United States, 80907-0000
        • Site Reference ID/Investigator# 124038
      • Denver, Colorado, United States, 80218
        • Site Reference ID/Investigator# 126202
    • Connecticut
      • Middlebury, Connecticut, United States, 06762-1835
        • Site Reference ID/Investigator# 123927
    • Florida
      • Clearwater, Florida, United States, 33756
        • Site Reference ID/Investigator# 123947
      • Jacksonville, Florida, United States, 32216
        • Site Reference ID/Investigator# 123929
      • Ocala, Florida, United States, 34471
        • Site Reference ID/Investigator# 123940
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 124166
      • Ponte Vedra Beach, Florida, United States, 32081
        • Site Reference ID/Investigator# 123945
    • Georgia
      • Dunwoody, Georgia, United States, 30338
        • Site Reference ID/Investigator# 123930
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Site Reference ID/Investigator# 124395
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Site Reference ID/Investigator# 125784
      • Lexington, Kentucky, United States, 40509
        • Site Reference ID/Investigator# 123919
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Site Reference ID/Investigator# 123925
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Site Reference ID/Investigator# 123936
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Site Reference ID/Investigator# 124160
      • Las Vegas, Nevada, United States, 89148
        • Site Reference ID/Investigator# 123939
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Site Reference ID/Investigator# 123932
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Site Reference ID/Investigator# 123943
    • New York
      • Garden City, New York, United States, 11530
        • Site Reference ID/Investigator# 123926
      • New York, New York, United States, 10016
        • Site Reference ID/Investigator# 125783
      • Poughkeepsie, New York, United States, 12601
        • Site Reference ID/Investigator# 123928
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Site Reference ID/Investigator# 124165
      • Morehead City, North Carolina, United States, 28557
        • Site Reference ID/Investigator# 123933
      • Salisbury, North Carolina, United States, 28144
        • Site Reference ID/Investigator# 123921
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Site Reference ID/Investigator# 124162
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Site Reference ID/Investigator# 123917
      • Jenkintown, Pennsylvania, United States, 19046
        • Site Reference ID/Investigator# 123931
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Site Reference ID/Investigator# 123924
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Site Reference ID/Investigator# 123895
      • Nashville, Tennessee, United States, 37203
        • Site Reference ID/Investigator# 123946
    • Texas
      • Austin, Texas, United States, 78705-2660
        • Site Reference ID/Investigator# 123923
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 123922
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 124167
      • San Antonio, Texas, United States, 78218
        • Site Reference ID/Investigator# 123944

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Low testosterone

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ABT-SLV176
ABT-SLV176 administered daily
Drug: ABT-SLV176
ABT-SLV176 administered daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects with serum total testosterone average concentration, Cavg(0-24)
Time Frame: At Week 12
Cavg (0-24) is the time-averaged Concentration Over the Dosing Interval of 24 Hours.
At Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax)
Time Frame: At Week 2, Week 4, Week 12 and Week 52
Cmax is the maximum concentration.
At Week 2, Week 4, Week 12 and Week 52
Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg)
Time Frame: At Week 2, Week 4, Week 12 and Week 52
Cavg is the average concentration.
At Week 2, Week 4, Week 12 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: Michael Miller, PharmD, AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (ESTIMATE)

March 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-886

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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