HypogonadismPhase 1/2NCT01887418

Pharmacokinetic Study of Testosterone Enanthate

A Phase 1/2 study testing QuickShot™ - 50 mg Treatment B, QuickShot™ - 100 mg Treatment A and Delatestryl 200 mg IM Treatment C in people with Hypogonadism, run by Antares Pharma Inc. at 1 site 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

Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate. Read more about this study

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Hypogonadism
What is being tested?: QuickShot™ - 50 mg Treatment B, QuickShot™ - 100 mg Treatment A and Delatestryl 200 mg IM Treatment C
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Jan 2014
Phase: Phase 1/2
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 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult males aged 18 to 75 with a documented diagnosis of hypogonadism

Who cannot join

Normal testosterone levels
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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mens Health Boston
Brookline, Massachusetts, 02445

Other trials in United States

About this study

Official title: 3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males

Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Read the detailed description

Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.

Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Conditions: Hypogonadism
Being tested: QuickShot™ - 50 mg Treatment B, QuickShot™ - 100 mg Treatment A, Delatestryl 200 mg IM Treatment C
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.

QuickShot™ - 50 mg Treatment BDrug
Also called Testosterone, Testosterone enanthate
QuickShot™ for the delivery of testosterone
QuickShot™ - 100 mg Treatment ADrug
Also called Testosterone, Testosterone enanthate
QuickShot™ for the delivery of testosterone
Delatestryl 200 mg IM Treatment CDrug
Also called Testosterone, Testosterone enanthate
Standard of care

Study groups in NCT01887418
Study group	Role	What they receive
QuickShot™ - 100 mg Treatment A	Experimental	QuickShot™Testosterone - Auto-injector device for SC use Receives: Drug: QuickShot™ - 100 mg Treatment A
QuickShot™ - 50 mg Treatment B	Experimental	QuickShot™Testosterone- Auto-injector device for SC use Receives: Drug: QuickShot™ - 50 mg Treatment B
Delatestryl 200 mg IM Treatment C	Active comparator	Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference Receives: Drug: Delatestryl 200 mg IM Treatment C

What is being measured

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

The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks
The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks
The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks
The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks

Secondary outcomes (1)

Number of Patients in the PK Parameter Category
The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE
Measured: 6 weeks

Timeline

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

Sep 2013Jan 2014

First posted26 Jun 2013 (estimated)
Study startSep 2013
Primary completionJan 2014
Study completionJan 2014

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01887418
Sponsor's protocol ID: QST-13-002
Status last verified: Dec 2017
First submitted: 17 Jun 2013
Last updated: 11 Jan 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

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All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males
ClinicalTrials.gov ID: NCT01887418
Acronym / sponsor ID: QST-13-002
Conditions: Hypogonadism
Keywords: Hypogonadism, Testosterone enanthate
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Antares Pharma Inc.Industry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 26 Jun 2013 (estimated)
Results: Posted 21 Oct 2015

Clinical summary

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

Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Detailed description

Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
QuickShot™ - 100 mg Treatment A	Experimental	Drug: QuickShot™ - 100 mg Treatment AQuickShot™Testosterone - Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B	Experimental	Drug: QuickShot™ - 50 mg Treatment BQuickShot™Testosterone- Auto-injector device for SC use
Delatestryl 200 mg IM Treatment C	Active comparator	Drug: Delatestryl 200 mg IM Treatment CCommercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference

Who may qualify

Ages: 18 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult males aged 18 to 75 with a documented diagnosis of hypogonadism

Key exclusion criteria (2 listed)

Normal testosterone levels
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

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
QuickShot™ - 50 mg Treatment BAlso: Testosterone, Testosterone enanthateQuickShot™ for the delivery of testosterone	Drug	QuickShot™ - 50 mg Treatment B
QuickShot™ - 100 mg Treatment AAlso: Testosterone, Testosterone enanthateQuickShot™ for the delivery of testosterone	Drug	QuickShot™ - 100 mg Treatment A
Delatestryl 200 mg IM Treatment CAlso: Testosterone, Testosterone enanthateStandard of care	Drug	Delatestryl 200 mg IM Treatment C

Primary outcome

The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST

1 secondary outcome

Number of Patients in the PK Parameter Category
Time frame: 6 weeks

Results and safety

Results posted to the registry on 21 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QuickShot™ - 100 mg Treatment A	15	15
QuickShot™ - 50 mg Treatment B	14	14
Delatestryl 200 mg IM Treatment C	10	9

Primary outcome: The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks

Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks. Mean (Standard Deviation). Unit: ng*hr/dL

Measure	QuickShot™ - 100 mg Treatment A n = 15	QuickShot™ - 50 mg Treatment B n = 14	Delatestryl 200 mg IM Treatment C n = 10
Value	150445.2 (46998.76)	70955.7 (20815.18)	278657.9 (168295.52)

Population analysed: PK profile of TT obtained at Week 6 of treatment by QST

Primary outcome: The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks

Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks. Mean (Standard Deviation). Unit: ng/dL

Measure	QuickShot™ - 100 mg Treatment A n = 15	QuickShot™ - 50 mg Treatment B n = 14	Delatestryl 200 mg IM Treatment C n = 10
Value	1345.6 (435.63)	622.4 (129.51)	261.9 (1310.34)

Population analysed: PK profile of TT obtained at Week 6 of treatment by QST

Primary outcome: The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks

Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks. Mean (Standard Deviation). Unit: ng/dL

Measure	QuickShot™ - 100 mg Treatment A n = 15	QuickShot™ - 50 mg Treatment B n = 14	Delatestryl 200 mg IM Treatment C n = 10
Value	895.5 (279.75)	422.4 (123.90)	1658.7 (1001.76)

Population analysed: PK profile of TT obtained at Week 6 of treatment by QST

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were classified as any adverse events that occurred from Day1 (after screening) to a given treatment period until the subject completed the study. The duration of the study participation for subjects was approximately 19 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QuickShot™ - 100 mg Treatment A	0 of 15 (0%)	7 of 15 (46.7%)	Not reported
QuickShot™ - 50 mg Treatment B	0 of 14 (0%)	6 of 14 (42.9%)	Not reported
Delatestryl 200 mg IM Treatment C	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 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.

Gary Bedel, MD principal investigator

Prestige Clinical Research

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

Questions about this trial

What is this clinical trial studying?

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 2 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 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 21 Oct 2015). 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?

The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks (time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks). The study lists 3 primary outcomes in all. 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 NCT01887418.

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 11 Jan 2018.