HypogonadismPhase 3NCT02082197

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

A Phase 3 study testing ABT-SLV176 in people with Hypogonadism and Testosterone Deficiency, run by AbbVie at 42 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, men only
Conditions the study is for: Hypogonadism, Testosterone Deficiency
What is being tested?: ABT-SLV176
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 42 sitesUnited States
Study dates: Mar 2014to Jun 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Low testosterone

Who cannot join

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

Trial locations and contacts

42 sites in 1 country.

City, postcode or hospital

42 sites in 1 country

United States42 sites

Site Reference ID/Investigator# 123943
Albuquerque, New Mexico, 87106
Site Reference ID/Investigator# 123948
Anaheim, California, 92801
Site Reference ID/Investigator# 123923
Austin, Texas, 78705-2660
Site Reference ID/Investigator# 123917
Bala-Cynwyd, Pennsylvania, 19004
Site Reference ID/Investigator# 123925
Baltimore, Maryland, 21287
Site Reference ID/Investigator# 124163
Birmingham, Alabama, 35213
Site Reference ID/Investigator# 124165
Charlotte, North Carolina, 28209
Site Reference ID/Investigator# 123895
Chattanooga, Tennessee, 37411
Site Reference ID/Investigator# 123947
Clearwater, Florida, 33756
Site Reference ID/Investigator# 124162
Cleveland, Ohio, 44122
Site Reference ID/Investigator# 124038
Colorado Springs, Colorado, 80907-0000
Site Reference ID/Investigator# 125784
Crestview Hills, Kentucky, 41017
Site Reference ID/Investigator# 123922
Dallas, Texas, 75231
Site Reference ID/Investigator# 124167
Dallas, Texas, 75231
Site Reference ID/Investigator# 126202
Denver, Colorado, 80218
Site Reference ID/Investigator# 123930
Dunwoody, Georgia, 30338
Site Reference ID/Investigator# 123926
Garden City, New York, 11530
Site Reference ID/Investigator# 123924
Greer, South Carolina, 29651
Site Reference ID/Investigator# 123938
Huntsville, Alabama, 35801
Site Reference ID/Investigator# 123929
Jacksonville, Florida, 32216
Site Reference ID/Investigator# 123931
Jenkintown, Pennsylvania, 19046
Site Reference ID/Investigator# 124160
Las Vegas, Nevada, 89121
Site Reference ID/Investigator# 123939
Las Vegas, Nevada, 89148
Site Reference ID/Investigator# 123932
Lawrenceville, New Jersey, 08648
Site Reference ID/Investigator# 123919
Lexington, Kentucky, 40509
Site Reference ID/Investigator# 124164
Los Angeles, California, 90069
Site Reference ID/Investigator# 123920
Los Gatos, California, 95032
Site Reference ID/Investigator# 125782
Mesa, Arizona, 85202
Site Reference ID/Investigator# 123936
Methuen, Massachusetts, 01844
Site Reference ID/Investigator# 123927
Middlebury, Connecticut, 06762-1835
Site Reference ID/Investigator# 123933
Morehead City, North Carolina, 28557
Site Reference ID/Investigator# 123946
Nashville, Tennessee, 37203
Site Reference ID/Investigator# 125783
New York, New York, 10016
Site Reference ID/Investigator# 123940
Ocala, Florida, 34471
Site Reference ID/Investigator# 124166
Orlando, Florida, 32806
Site Reference ID/Investigator# 124157
Phoenix, Arizona, 85032
Site Reference ID/Investigator# 123945
Ponte Vedra Beach, Florida, 32081
Site Reference ID/Investigator# 123928
Poughkeepsie, New York, 12601
Site Reference ID/Investigator# 123921
Salisbury, North Carolina, 28144
Site Reference ID/Investigator# 123944
San Antonio, Texas, 78218
Site Reference ID/Investigator# 123937
Tucson, Arizona, 85712
Site Reference ID/Investigator# 124395
Wichita, Kansas, 67226

Other trials in United States

About this study

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

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.

Conditions: Hypogonadism, Testosterone Deficiency
Being tested: ABT-SLV176
Keywords: low testosterone
Medical subject headings: Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-SLV176Drug
ABT-SLV176 administered daily

Study groups in NCT02082197
Study group	Role	What they receive
ABT-SLV176	Experimental	ABT-SLV176 administered daily Receives: Drug: ABT-SLV176

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax)
Cmax is the maximum concentration.
Measured: At Week 2, Week 4, Week 12 and Week 52
Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg)
Cavg is the average concentration.
Measured: At Week 2, Week 4, Week 12 and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Jun 2015

First posted10 Mar 2014 (estimated)
Study startMar 2014
Primary completionJun 2015 (estimated)
Study completionJun 2015 (estimated)

Why it stopped: Other - not a safety issue

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypogonadismStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02082197
Sponsor's protocol ID: M13-886
Status last verified: May 2014
First submitted: 6 Mar 2014
Last updated: 2 Jun 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship

All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label, Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men
ClinicalTrials.gov ID: NCT02082197
Acronym / sponsor ID: M13-886
Conditions: Hypogonadism, Testosterone Deficiency
Keywords: low testosterone
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Other - not a safety issue
Enrolment: 0 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Jun 2015 (estimated)
Study completion: Jun 2015 (estimated)
First posted: 10 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ABT-SLV176	Experimental	Drug: ABT-SLV176ABT-SLV176 administered daily

Who may qualify

Ages: 18 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Low testosterone

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABT-SLV176ABT-SLV176 administered daily	Drug	ABT-SLV176

Primary outcome

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.

2 secondary outcomes

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
Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg)
Time frame: At Week 2, Week 4, Week 12 and Week 52

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.

Related trials for Hypogonadism

RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Miller, PharmD study director

AbbVie

42 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-SLV176 in people with Hypogonadism and Testosterone Deficiency, run by AbbVie at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with serum total testosterone average concentration, Cavg(0-24) (time frame: At Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02082197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.