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Clinical Trials/NCT02082197
NCT02082197WithdrawnPhase 3

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

AbbVie42 sites in 1 countryStarted: March 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Withdrawn
Sponsor
Locations
42
Primary Endpoint
Percentage of subjects with serum total testosterone average concentration, Cavg(0-24)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Low testosterone

Exclusion Criteria

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

Arms & Interventions

ABT-SLV176

Experimental

ABT-SLV176 administered daily

Intervention: ABT-SLV176 (Drug)

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)

Investigators

Sponsor
AbbVie
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (42)

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