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

Phase 3

Withdrawn

• Conditions: Hypogonadism; Testosterone Deficiency
• Interventions: Drug: ABT-SLV176

• Registration Number: NCT02082197
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-06-02
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Low testosterone

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABT-SLV176	ABT-SLV176	ABT-SLV176 administered daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Cmax is the maximum concentration.
Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg)	At Week 2, Week 4, Week 12 and Week 52	Cavg is the average concentration.

Trial Locations

Locations (42)

Site Reference ID/Investigator# 124163; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 123938; 🇺🇸 Huntsville, Alabama, United States

Site Reference ID/Investigator# 125782; 🇺🇸 Mesa, Arizona, United States

Site Reference ID/Investigator# 124157; 🇺🇸 Phoenix, Arizona, United States

Site Reference ID/Investigator# 123937; 🇺🇸 Tucson, Arizona, United States

Site Reference ID/Investigator# 123948; 🇺🇸 Anaheim, California, United States

Site Reference ID/Investigator# 124164; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator# 123920; 🇺🇸 Los Gatos, California, United States

Site Reference ID/Investigator# 124038; 🇺🇸 Colorado Springs, Colorado, United States

Site Reference ID/Investigator# 126202; 🇺🇸 Denver, Colorado, United States

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