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Rogol AD, Tkachenko N, Badorrek P, et al. Phase 1 pharmacokinetics and phase 3 efficacy of testosterone nasal gel in subjects with seasonal allergies. Can Urol Assoc J. 2018;12(7):E349-E356doi: 10.5489/cuaj.4898.
Rogol, A. D., Tkachenko, N., Badorrek, P., Hohlfeld, J. M., & Bryson, N. (2018). Phase 1 pharmacokinetics and phase 3 efficacy of testosterone nasal gel in subjects with seasonal allergies. Canadian Urological Association journal = Journal de l'Association des urologues du Canada, 12(7), E349-E356. https://doi.org/10.5489/cuaj.4898
Rogol, Alan D, et al. "Phase 1 pharmacokinetics and phase 3 efficacy of testosterone nasal gel in subjects with seasonal allergies." Canadian Urological Association journal = Journal de l'Association des urologues du Canada vol. 12,7 (2018): E349-E356. doi: https://doi.org/10.5489/cuaj.4898
Rogol AD, Tkachenko N, Badorrek P, Hohlfeld JM, Bryson N. Phase 1 pharmacokinetics and phase 3 efficacy of testosterone nasal gel in subjects with seasonal allergies. Can Urol Assoc J. 2018 Jul;12(7):E349-E356. doi: 10.5489/cuaj.4898. Epub 2018 Mar 19. PMID: 29603916; PMCID: PMC6118055.
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Can Urol Assoc J. 2018 Jul;12(7):E349-E356. doi: 10.5489/cuaj.4898. Epub 2018 Mar 19.

Phase 1 pharmacokinetics and phase 3 efficacy of testosterone nasal gel in subjects with seasonal allergies.

Canadian Urological Association journal = Journal de l'Association des urologues du Canada

Alan D Rogol, Natalia Tkachenko, Philipp Badorrek, Jens M Hohlfeld, Nathan Bryson

Affiliations

  1. University of Virginia, Charlottesville, VA, United States.
  2. Amgen Canada Inc., Mississauga, ON, Canada.
  3. Acerus Pharmaceuticals Corp, Mississauga, ON, Canada.
  4. Fraunhofer Institute for Toxicology and Experimental Medicine (FITEM), Hannover, Germany and German Centre for Lung Research, Geissen, Germany.

PMID: 29603916 PMCID: PMC6118055 DOI: 10.5489/cuaj.4898

Abstract

INTRODUCTION: NATESTO

METHODS: The 24-hour pharmacokinetics (PK) and relative bioavailability of serum total testosterone (sTT) from TNG (11 mg tid ) were determined using a phase 1 Latin-square design with 18 eugonadal AR subjects crossed over between asymptomatic, symptomatic-untreated, and symptomatic-treated (oxymetazoline) conditions. Allergy symptoms, assessed using Total Nasal Symptom Score (TNSS), were induced using grass pollen in an allergy challenge chamber (ACC) prior to administration of TNG. The data are discussed in relation to results from a phase 3 study in 306 hypogonadal patients which compare clinical outcomes of AR and non-AR patients treated with TNG.

RESULTS: PK analysis (T

CONCLUSIONS: AR does not affect absorption of TNG. Patient outcomes for long-term treatment with TNG for up to one year are not dependent on AR history.

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