HypogonadismPhase 2NCT02777242
Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism
A Phase 2 study testing Testosterone enanthate auto-injector in people with Hypogonadism, run by Antares Pharma Inc. at 3 sites in United States.
Trial summary
Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single dose via QuickShot® Testosterone (QST) when administered by intended users in a usability study. 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
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2016to Aug 2016
- Phase
- Phase 2
- 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
- Each patient must meet all of the following criteria at screening to participate in the study:
- The patient is 18 years of age or older;
- The patient speaks, reads, and understands the English language at a sixth grade reading level or higher;
- The patient is willing to have photographs taken and/or be video recorded while he completes study tasks, which will be de-identified prior to any potential use of the image(s) for scientific or educational purposes;
- The patient has sufficient availability to participate in the study and to comply with the study schedule;
- The patient has his own transportation to and from the study site;
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- The patient demonstrates the ability to understand and the willingness to follow all study instructions; and
- The patient has read, stated he understands, and has signed the Informed Consent Form (ICF).
- The patient has been diagnosed with hypogonadism;
- The patient is a male;
- The patient has a documented history of hypogonadism. Diagnosis must include documentation of consistent signs and symptoms of androgen deficiency;
- Patients in good health as determined by the Investigator and based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests;
- All male patients must practice effective contraception during the study and for 30 days after receiving the last dose of study drug. Acceptable methods of birth control include condom with spermicide, vasectomy, or monogamous relations with a female partner who is of non child-bearing potential (post-menopausal, surgical, or congenital sterility) or is of child bearing potential and practicing a reliable method of contraception (hormonal contraception, double barrier methods with spermicide, or intrauterine device); and
- Patients must have the ability to provide written informed consent and comply with all study requirements and restrictions including the study visit schedule.
Who cannot join
- Patients will be excluded from participation in the study if any of the following criteria apply:
- Failure to meet 1 or more Inclusion Criterion;
- The patient has participated in interviews, focus groups, or studies for any medical products or therapies within the past 3 months or in a prior QST auto-injector usability study, clinical trial, and/or has previous exposure to the investigational device;
- The patient or someone he lives with works or has worked for a Marketing/Market Research Company, pharmaceutical or medical device company, a manufacturer, distributor, or wholesaler of non-prescription drug products, or a government health agency;
- Individuals who have had an allergic reaction or idiosyncratic reaction to sesame seeds, sesame products, and/or sesame oil;
- History of food anaphylaxis;
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- History of intolerance, allergy, or idiosyncratic reaction to testosterone products;
- Unstable psychiatric illnesses;
- Lifetime history of psychosis, suicidal behavior, bipolar disorder, or personality disorder; active suicidal ideation within 6 months prior to screening; or inadequately treated depression. Note: Patients with depression who have been adequately treated and with stable response for 3 months may be admitted into the study at the Investigator's discretion;
- Body mass index 40 kg/m2;
- Hematocrit 52% at Initial Screening Visit;
- Individual history or current evidence of breast or prostate cancer;
- Other malignancy diagnosed or treated within 5 years of the date of Initial Screening Visit with the exception of non-melanoma carcinoma of the skin;
- Elevated prostate-specific antigen (PSA) for age. Prostate-specific antigen 2.5 ng/mL in men 18 to 60 years old and 4 ng/mL in men 61 years and older is exclusionary;
- Presence of prostate nodule or induration upon digital rectal exam;
- Obstructive uropathy of prostatic origin and of a severity that, in the opinion of the Investigator, contraindicates the use of testosterone;
- Patients with poorly controlled diabetes. Patients on a stable dose and regimen of anti diabetic medications for a minimum of 4 weeks, and who have a hemoglobin A1c level of 7.5% may participate in the study;
- Patients with New York Heart Association Class III or IV congestive heart failure;
- Within 6 months of the Initial Screening Visit, have had myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease;
- History of, or current treatment for, thromboembolic disease or current use of anti thromboembolic medications. Use of low-dose aspirin is permitted for routine cardioprophylaxis;
- Patients intermittently taking adrenocorticotropic hormone, oral, or depot corticosteroids (ongoing regimens required for panhypopituitarism or adrenal failure are permitted);
- Untreated sleep apnea;
- Historical or current evidence of any clinically significant disease or disorder that, in the judgment of the Investigator, may cause participation in this study to be detrimental to the patient or which may influence the results of the study. This includes cardiovascular, renal, hepatic, hematological, endocrine, gastrointestinal, or pulmonary disease;
- Positive serology for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibody at the Initial Screening Visit;
- Current evidence of alcohol or drug abuse. A positive drug screen is exclusionary without documentation of a current prescription and medical condition requiring treatment with the drug for which the screen is positive. Exception: tetrahydrocannabinol is allowed in states where recreational use of marijuana is legal;
- Any skin condition that could confound injection site assessments (eg, dermatographism, urticaria, or atopic dermatitis). Tattoos, scarring, or psoriasis of the injection site is prohibited;
- Administration of any other investigational compound within 1 month prior to Initial Screening Visit or 5 half-lives of the investigational product (whichever is longer);
- Patients considering or scheduled to undergo any major surgery or dental procedure anticipated to be associated with significant blood loss (500 mL) during the study;
- Systolic blood pressure (SBP) 140 mmHg and/or diastolic blood pressure (DBP) 90 mmHg at the Initial Screening Visit. Patients with treated hypertension and SBP 140 and/or DBP 90 mmHg at the Initial Screening Visit must be on a stable dose of antihypertensive medication for at least 14 days at Day -1 (Baseline Visit) and plan to remain on the same dose throughout the duration of the study; or
- Unable to understand verbal or written English or any other language in which a certified translation of the informed consent is available.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Birmingham, Alabama, 35235
Study site
Columbus, Ohio, 43213
Study site
New York, New York, 10016
About this study
Official title: An Open-Label Study to Evaluate the Safety of Testosterone Enanthate After Two Single-Dose Injections Via QuickShot® Testosterone by Intended Users and QuickShot™ Summative Usability Study
Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single dose via QuickShot® Testosterone (QST) when administered by intended users in a usability study.
Read the detailed description
Intended users are patients as well as patient caregivers, such as family members or friends who are able to assist the patient to administer the medication (i.e. lay users). One user group of approximately 15 patients will have their dose administered by a qualified healthcare professional (HCP).
- 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)
SC injections of QST 50 mg or 75 mg or 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Testosterone enanthate auto-injector | Experimental | Testosterone enanthate administered subcutaneously once each week. Auto-injection of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)] Receives: Combination Product: Testosterone enanthate auto-injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antares Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jed Kaminetsky, MD, Principal investigator, Manhattan Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777242
- Sponsor's protocol ID
- QST-16-006
- Status last verified
- Feb 2018
- First submitted
- 12 May 2016
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety of Testosterone Enanthate After Two Single-Dose Injections Via QuickShot® Testosterone by Intended Users and QuickShot™ Summative Usability Study
- ClinicalTrials.gov ID
- NCT02777242
- Acronym / sponsor ID
- QST-16-006
- Conditions
- Hypogonadism
- Keywords
- Hypogonadism, Testosterone enanthate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Antares Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Posted 26 Feb 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 the safety and tolerability of testosterone enanthate (TE) following a single dose via QuickShot® Testosterone (QST) when administered by intended users in a usability study.
Detailed description
Intended users are patients as well as patient caregivers, such as family members or friends who are able to assist the patient to administer the medication (i.e. lay users). One user group of approximately 15 patients will have their dose administered by a qualified healthcare professional (HCP).
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 administered subcutaneously once each week. Auto-injection of QST 50 mg or 75 mg or 100 mg [Device: QuickShot® Testosterone (QST)] |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Each patient must meet all of the following criteria at screening to participate in the study:
- The patient is 18 years of age or older;
- The patient speaks, reads, and understands the English language at a sixth grade reading level or higher;
- The patient is willing to have photographs taken and/or be video recorded while he completes study tasks, which will be de-identified prior to any potential use of the image(s) for scientific or educational purposes;
- The patient has sufficient availability to participate in the study and to comply with the study schedule;
Key exclusion criteria (30 listed)
- Patients will be excluded from participation in the study if any of the following criteria apply:
- Failure to meet 1 or more Inclusion Criterion;
- The patient has participated in interviews, focus groups, or studies for any medical products or therapies within the past 3 months or in a prior QST auto-injector usability study, clinical trial, and/or has previous exposure to the investigational device;
- The patient or someone he lives with works or has worked for a Marketing/Market Research Company, pharmaceutical or medical device company, a manufacturer, distributor, or wholesaler of non-prescription drug products, or a government health agency;
- Individuals who have had an allergic reaction or idiosyncratic reaction to sesame seeds, sesame products, and/or sesame oil;
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)SC injections of QST 50 mg or 75 mg or 100 mg | Combination product | Testosterone enanthate auto-injector |
Primary outcome
Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
Time frame: 3 weeks
Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone enanthate auto-injector in people with Hypogonadism, run by Antares Pharma Inc. at 3 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 14 inclusion and 30 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Feb 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?
Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2018.