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Clinical Trials/NCT02082197
NCT02082197
Withdrawn
Phase 3

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

AbbVie42 sites in 1 countryMarch 2014
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ConditionsHypogonadismTestosterone Deficiency
InterventionsABT-SLV176
DrugsABT-SLV176

Overview

Phase
Phase 3
Intervention
ABT-SLV176
Conditions
Hypogonadism
Sponsor
AbbVie
Locations
42
Primary Endpoint
Percentage of subjects with serum total testosterone average concentration, Cavg(0-24)
Status
Withdrawn
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
June 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
AbbVie
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Low testosterone

Exclusion Criteria

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

Arms & Interventions

ABT-SLV176

ABT-SLV176 administered daily

Intervention: ABT-SLV176

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 Sites (42)

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