Pharmacokinetic Profile of Subcutaneous Testosterone Enanthate Delivered via a Novel, Prefilled Single-Use Autoinjector: A Phase II Study

Sexual Medicine
Jed KaminetskyR S Swerdloff

Abstract

Hypogonadism is one of the most common male endocrine problems. Although many treatments are currently available, unmet need exists for new testosterone (T) replacement therapies that are simple to administer and use, are safe, and mimic physiologic T levels. The study aim was to determine the pharmacokinetics (PK), safety, and tolerability of T enanthate (TE) administered via a novel single-use autoinjector system, which was designed to eject high-viscosity solutions from a prefilled syringe fitted with a five-eighths-inch 27-gauge needle. Thirty-nine men with hypogonadism entered this dose-finding, open-label, parallel-group study. Patients were washed out of their topical T regimens and randomized to receive 50 or 100 mg of subcutaneous (SC) TE weekly. The reference group were patients with hypogonadism who were maintained on standard 200-mg intramuscular (IM) TE. The primary outcome measure was the PK profile of SC TE, analyzed in reference to T levels used by the Food and Drug Administration to approve T products. Secondary outcome measures were safety and tolerability assessments. Both doses of SC TE achieved normal average concentrations of serum T within a 168-h dosing interval after injection. Concentration ranges were...Continue Reading

References

May 26, 1999·Clinical Endocrinology·S Parker, M Armitage
Jul 21, 2004·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Steven M PetakUNKNOWN American Association of Clinical Endocrinologists
Dec 8, 2004·The Journal of Clinical Endocrinology and Metabolism·Andre B AraujoJohn B McKinlay
Aug 16, 2006·Archives of Internal Medicine·Molly M ShoresDaniel R Kivlahan
Aug 19, 2007·The Journal of Clinical Endocrinology and Metabolism·Andre B AraujoJohn B McKinlay
Apr 23, 2008·Expert Opinion on Drug Delivery·Emily Pfeil, Adrian S Dobs
Jan 28, 2009·The Aging Male : the Official Journal of the International Society for the Study of the Aging Male·Claudia MatternCorin Badiu
Sep 1, 2007·Journal of Diabetes Science and Technology·Harvinder S Gill, Mark R Prausnitz
Feb 2, 2010·Asian Journal of Andrology·Gideon SartoriusDavid J Handelsman
Jun 9, 2010·The Journal of Clinical Endocrinology and Metabolism·Shalender BhasinUNKNOWN Task Force, Endocrine Society
Apr 17, 2012·International Journal of Endocrinology·Prasanth N SurampudiRonald Swerdloff
Aug 14, 2013·JAMA Internal Medicine·Jacques BaillargeonJames S Goodwin
Nov 7, 2013·JAMA : the Journal of the American Medical Association·Rebecca VigenP Michael Ho
Dec 19, 2013·The Journal of Sexual Medicine·Jason R KovacLarry I Lipshultz
Mar 29, 2014·International Journal of Clinical Practice·E F ShortridgeB Carswell
Jul 6, 2014·The Annals of Pharmacotherapy·Jacques BaillargeonJames S Goodwin

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Citations

Jan 26, 2018·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·David M WilsonMary H H Ensom
Jan 31, 2019·Endocrine Reviews·Jacques YoungNelly Pitteloud
Dec 22, 2017·Journal of the Endocrine Society·Julie McFarlandDaniel I Spratt
Aug 7, 2019·Journal of the Endocrine Society·Leo TurnerDavid J Handelsman
Dec 10, 2020·Journal of the Endocrine Society·Maria VogiatziAlan D Rogol
Feb 22, 2021·Ageing Research Reviews·Nikolai JaschkeTilman D Rachner
May 20, 2021·International Journal of Impotence Research·Edward J ChoiFaysal A Yafi
Oct 27, 2021·The Journal of Clinical Endocrinology and Metabolism·Maria Gabriela FigueiredoShehzad Basaria
Nov 24, 2021·Clinical Endocrinology·Channa N JayasenaRichard Quinton

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Methods Mentioned

BETA
ISA

Clinical Trials Mentioned

NCT01887418

Software Mentioned

SAS®

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