Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082197
Recruitment Status : Withdrawn (Other - not a safety issue)
First Posted : March 10, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypogonadism Testosterone Deficiency Drug: ABT-SLV176 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men
Study Start Date : March 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: ABT-SLV176
ABT-SLV176 administered daily
Drug: ABT-SLV176
ABT-SLV176 administered daily




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Low testosterone

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082197


Locations
Show Show 42 study locations
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: Michael Miller, PharmD AbbVie
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02082197    
Other Study ID Numbers: M13-886
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Keywords provided by AbbVie:
low testosterone
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypogonadism
Gonadal Disorders
Endocrine System Diseases