HypogonadismPhase 3STEADYNCT02159469

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism

A Phase 3 study testing Testosterone enanthate auto-injector in people with Hypogonadism, run by Antares Pharma Inc. at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hypogonadism
What is being tested?: Testosterone enanthate auto-injector
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 28 sitesUnited States
Study dates: Jul 2014to Nov 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism
Total testosterone levels < 300 ng/dL at two qualification visits
Patients in good general health

Who cannot join

Allergy to sesame or testosterone products
BMI ≥ 40 kg/m2
Hematocrit ≥ 52%
History or current evidence of breast or prostate cancer
Elevated PSA (Prostate-Specific Antigen) for age.
Abnormal DRE (digital rectal examination)

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Obstructive uropathy of prostatic origin
Poorly controlled diabetes
Congestive heart failure
Within 6 months of screening, MI (myocardial ischemia), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
History or current treatment of thromboembolic disease.
Use of ACTH (adrenocorticotropic hormone) or oral/depot corticosteroids within 6 weeks of screening.
History of severe, untreated sleep apnea
Subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
Positive serology for HIV, hepatitis B or hepatitis C
Current evidence of drug or alcohol abuse.
Skin conditions in injection site that could confound injection site assessments.
Administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer).
Use of estrogen, GnRH (gonadotropin-releasing hormone) or growth hormone within 12 months of screening.
Use of other androgens (DHEA(Dehydroepiandrosterone), anabolic steroids, other sex hormones) or other substances/supplements know to affect the PK (pharmacokinetics) of testosterone enanthate
Considered or scheduled surgical or dental procedures associated with blood loss ≥500 mL during study.
Donation of plasma or blood within 56 days of screening or history of donation of > 50 mL of blood or plasma within 3 months of screening.
Donation of plasma or blood during study

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Study site
Albany, New York
Study site
Birmingham, Alabama
Study site
Brookline, Massachusetts
Study site
Burbank, California
Study site
Franklin, Ohio
Study site
Huntsville, Alabama
Study site
Jacksonville, Florida
Study site
Kansas City, Missouri
Study site
Lawrenceville, New Jersey
Study site
Lexington, Kentucky
Study site
Medford, Oregon
Study site
Methuen, Massachusetts
Study site
Mt. Pleasant, South Carolina
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Oviedo, Florida
Study site
Renton, Washington
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
San Antonio, Texas
Study site
Shreveport, Louisiana
Study site
Sugar Land, Texas
Study site
Torrance, California
Study site
Tucson, Arizona
Study site
Upland, California
Study site
Warwick, Rhode Island
Study site
West Valley City, Utah

Other trials in United States

About this study

Official title: A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector

Read the detailed description

This study will evaluate, if testosterone enanthate administered subcutaneously once each week by an auto-injector to men with low testosterone, can raise their levels into the normal range.

The study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations.

Safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use.

Conditions: Hypogonadism
Being tested: Testosterone enanthate auto-injector
Keywords: Hypogonadism, Testosterone enanthate
Medical subject headings: Hypogonadism

What participants receive

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

Testosterone enanthate auto-injectorCombination product
Also called Testosterone, Testosterone enanthate, QuickShot® Testosterone (QST)
Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels

Study groups in NCT02159469
Study group	Role	What they receive
Testosterone enanthate auto-injector	Experimental	Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study. Receives: Combination Product: Testosterone enanthate auto-injector

What is being measured

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

Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.
Measured: 12 weeks

Secondary outcomes (1)

Safety and Tolerability
- Incidence of adverse events throughout the study
- Incidence and severity of injection site reactions throughout the study
Measured: 52 weeks

Timeline

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

Jul 2014Nov 2015

First posted10 Jun 2014 (estimated)
Study startJul 2014
Primary completionFeb 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypogonadismStudies of the same condition, open and under way.
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: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02159469
Sponsor's protocol ID: QST-13-003
Acronym: STEADY
Status last verified: Jan 2018
First submitted: 6 Jun 2014
Last updated: 7 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
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 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism
ClinicalTrials.gov ID: NCT02159469
Acronym / sponsor ID: STEADY / QST-13-003
Conditions: Hypogonadism
Keywords: Hypogonadism, Testosterone enanthate
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Antares Pharma Inc.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Feb 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 10 Jun 2014 (estimated)
Results: Posted 9 Jan 2018

Clinical summary

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

Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector

Detailed description

This study will evaluate, if testosterone enanthate administered subcutaneously once each week by an auto-injector to men with low testosterone, can raise their levels into the normal range.

The study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations.

Safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use.

Study design

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

Arm	Type	Receives
Testosterone enanthate auto-injector	Experimental	Combination Product: Testosterone enanthate auto-injectorTestosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.

Who may qualify

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

Key inclusion criteria (3 listed)

Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism
Total testosterone levels < 300 ng/dL at two qualification visits
Patients in good general health

Key exclusion criteria (23 listed)

Allergy to sesame or testosterone products
BMI ≥ 40 kg/m2
Hematocrit ≥ 52%
History or current evidence of breast or prostate cancer
Elevated PSA (Prostate-Specific Antigen) for age.

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
Testosterone enanthate auto-injectorAlso: Testosterone, Testosterone enanthate, QuickShot® Testosterone (QST)Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels	Combination product	Testosterone enanthate auto-injector

Primary outcome

Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
Time frame: 12 weeks
The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.

1 secondary outcome

Safety and Tolerability
Time frame: 52 weeks

Results and safety

Results posted to the registry on 9 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QST 50 mg / 75 mg / 100 mg	150	97

Primary outcome: Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Testosterone Enanthate Auto-injector n = 150
Value	139

Population analysed: The Population consisted of all patients who received at least 1 dose of the investigational product. Percentage was calculated using the number of patients in the column heading as the denominator.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Testosterone Enanthate Auto-injector	3 of 150 (2%)	125 of 150 (83.3%)	1 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Jed Kaminetsky, MD principal investigator

Manhattan Medical Research Practice

28 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 Testosterone enanthate auto-injector in people with Hypogonadism, run by Antares Pharma Inc. at 28 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 3 inclusion and 23 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: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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?

Yes. Results are posted in the registry (first posted 9 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) (time frame: 12 weeks). 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 NCT02159469.

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 7 Feb 2018.