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Pharmacokinetic Study of Testosterone Enanthate

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01887418
Enrollment
39
Registered
2013-06-26
Start date
2013-09-30
Completion date
2014-01-31
Last updated
2018-01-11

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

Conditions

Hypogonadism

Keywords

Hypogonadism, Testosterone enanthate

Brief summary

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

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.

Interventions

DRUGQuickShot™ - 50 mg Treatment B

QuickShot™ for the delivery of testosterone

DRUGQuickShot™ - 100 mg Treatment A

QuickShot™ for the delivery of testosterone

DRUGDelatestryl 200 mg IM Treatment C

Standard of care

Sponsors

Antares Pharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 WeeksThe 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 Weeks0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 WeeksThe 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 Weeks0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 WeeksThe average concentration \[Cavg\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST

Secondary

MeasureTime frameDescription
Number of Patients in the PK Parameter Category6 weeksThe 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

Countries

United States

Participant flow

Recruitment details

Subjects were screened at 10 sites in USA. In total, 39 eligible subjects were enrolled and received study medication (investigational SC QST or IM RLD): 14 subjects in 50 mg SC QST arm, 15 subjects in 100 mg SC QST arm and 10 subjects in 200 mg IM RLD arm.

Pre-assignment details

Eligible patients were randomized to receive SC 50mg (Treatment B) or SC 100mg (Treatment A) QST and the subject who were on IM testosterone replacement therapy, received IM TE RLD (Treatment C).

Participants by arm

ArmCount
QuickShot™ - 100 mg Treatment A
QuickShot™ - Auto-injector device for SC use QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week for 6 weeks
15
QuickShot™ - 50 mg Treatment B
QuickShot™ - Auto-injector device for SC use QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week for 6 weeks
14
Delatestryl 200 mg IM Treatment C
Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference Delatestryl 200 mg IM Treatment C: injected once only
10
Total39

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyTravelling difficulties001

Baseline characteristics

CharacteristicQuickShot™ - 100 mg Treatment AQuickShot™ - 50 mg Treatment BDelatestryl 200 mg IM Treatment CTotal
Age, Continuous54.7 years
STANDARD_DEVIATION 12.8
54.0 years
STANDARD_DEVIATION 12.42
48.9 years
STANDARD_DEVIATION 10.94
52.9 years
STANDARD_DEVIATION 12.14
Baseline Total Testosterone (TT) (ng/dL)201.50 ng/dL
STANDARD_DEVIATION 71.53
214.64 ng/dL
STANDARD_DEVIATION 59.05
735.10 ng/dL
STANDARD_DEVIATION 187.96
343.04 ng/dL
STANDARD_DEVIATION 256.67
Body Mass Index (BMI) at screening (kg/m^2)29.19 kg/m^2
STANDARD_DEVIATION 2.87
28.51 kg/m^2
STANDARD_DEVIATION 2.17
29.05 kg/m^2
STANDARD_DEVIATION 2.21
28.91 kg/m^2
STANDARD_DEVIATION 2.43
Race/Ethnicity, Customized
African American
2 participants0 participants1 participants3 participants
Race/Ethnicity, Customized
Multiple
0 participants0 participants1 participants1 participants
Race/Ethnicity, Customized
White
13 participants14 participants8 participants35 participants
Region of Enrollment
United States
15 participants14 participants10 participants39 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
15 Participants14 Participants10 Participants39 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
7 / 156 / 140 / 10
serious
Total, serious adverse events
0 / 150 / 140 / 10

Outcome results

Primary

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

Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks

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

ArmMeasureValue (MEAN)Dispersion
QuickShot™ - 100 mg Treatment AThe Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks150445.2 ng*hr/dLStandard Deviation 46998.76
QuickShot™ - 50 mg Treatment BThe Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks70955.7 ng*hr/dLStandard Deviation 20815.18
Delatestryl 200 mg IM Treatment CThe Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks278657.9 ng*hr/dLStandard Deviation 168295.52
Primary

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

Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks

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

ArmMeasureValue (MEAN)Dispersion
QuickShot™ - 100 mg Treatment AThe Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks895.5 ng/dLStandard Deviation 279.75
QuickShot™ - 50 mg Treatment BThe Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks422.4 ng/dLStandard Deviation 123.9
Delatestryl 200 mg IM Treatment CThe Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks1658.7 ng/dLStandard Deviation 1001.76
Primary

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

Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks

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

ArmMeasureValue (MEAN)Dispersion
QuickShot™ - 100 mg Treatment AThe Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks1345.6 ng/dLStandard Deviation 435.63
QuickShot™ - 50 mg Treatment BThe Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks622.4 ng/dLStandard Deviation 129.51
Delatestryl 200 mg IM Treatment CThe Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks261.9 ng/dLStandard Deviation 1310.34
Secondary

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

Time frame: 6 weeks

ArmMeasureValue (NUMBER)
QuickShot™ - 100 mg Treatment ANumber of Patients in the PK Parameter Category10 participants
QuickShot™ - 50 mg Treatment BNumber of Patients in the PK Parameter Category12 participants
Delatestryl 200 mg IM Treatment CNumber of Patients in the PK Parameter Category3 participants

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