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

NCT ID: NCT02082197

Last Updated: 2014-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypogonadism Testosterone Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-SLV176

ABT-SLV176 administered daily

Group Type EXPERIMENTAL

ABT-SLV176

Intervention Type DRUG

ABT-SLV176 administered daily

Interventions

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ABT-SLV176

ABT-SLV176 administered daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Low testosterone

Exclusion Criteria

* Normal testosterone levels
* Elevated Prostatic Specific Antigen (PSA)
* History of breast or prostate cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Miller, PharmD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 124163

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 123938

Huntsville, Alabama, United States

Site Status

Site Reference ID/Investigator# 125782

Mesa, Arizona, United States

Site Status

Site Reference ID/Investigator# 124157

Phoenix, Arizona, United States

Site Status

Site Reference ID/Investigator# 123937

Tucson, Arizona, United States

Site Status

Site Reference ID/Investigator# 123948

Anaheim, California, United States

Site Status

Site Reference ID/Investigator# 124164

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 123920

Los Gatos, California, United States

Site Status

Site Reference ID/Investigator# 124038

Colorado Springs, Colorado, United States

Site Status

Site Reference ID/Investigator# 126202

Denver, Colorado, United States

Site Status

Site Reference ID/Investigator# 123927

Middlebury, Connecticut, United States

Site Status

Site Reference ID/Investigator# 123947

Clearwater, Florida, United States

Site Status

Site Reference ID/Investigator# 123929

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 123940

Ocala, Florida, United States

Site Status

Site Reference ID/Investigator# 124166

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 123945

Ponte Vedra Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 123930

Dunwoody, Georgia, United States

Site Status

Site Reference ID/Investigator# 124395

Wichita, Kansas, United States

Site Status

Site Reference ID/Investigator# 125784

Crestview Hills, Kentucky, United States

Site Status

Site Reference ID/Investigator# 123919

Lexington, Kentucky, United States

Site Status

Site Reference ID/Investigator# 123925

Baltimore, Maryland, United States

Site Status

Site Reference ID/Investigator# 123936

Methuen, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 124160

Las Vegas, Nevada, United States

Site Status

Site Reference ID/Investigator# 123939

Las Vegas, Nevada, United States

Site Status

Site Reference ID/Investigator# 123932

Lawrenceville, New Jersey, United States

Site Status

Site Reference ID/Investigator# 123943

Albuquerque, New Mexico, United States

Site Status

Site Reference ID/Investigator# 123926

Garden City, New York, United States

Site Status

Site Reference ID/Investigator# 125783

New York, New York, United States

Site Status

Site Reference ID/Investigator# 123928

Poughkeepsie, New York, United States

Site Status

Site Reference ID/Investigator# 124165

Charlotte, North Carolina, United States

Site Status

Site Reference ID/Investigator# 123933

Morehead City, North Carolina, United States

Site Status

Site Reference ID/Investigator# 123921

Salisbury, North Carolina, United States

Site Status

Site Reference ID/Investigator# 124162

Cleveland, Ohio, United States

Site Status

Site Reference ID/Investigator# 123917

Bala-Cynwyd, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 123931

Jenkintown, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 123924

Greer, South Carolina, United States

Site Status

Site Reference ID/Investigator# 123895

Chattanooga, Tennessee, United States

Site Status

Site Reference ID/Investigator# 123946

Nashville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 123923

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 123922

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 124167

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 123944

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M13-886

Identifier Type: -

Identifier Source: org_study_id

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