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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02082197

Enrollment

Registered

2014-03-10

Start date

2014-03-31

Completion date

2015-06-30

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism, Testosterone Deficiency

Keywords

low testosterone

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.

Interventions

DRUGABT-SLV176

ABT-SLV176 administered daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Low testosterone

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026