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Randomized Controlled Trial
. 2021 Apr;28(4):376-381.
doi: 10.1111/iju.14468. Epub 2020 Dec 19.

Efficacy of testosterone replacement therapy plus alternate-day tadalafil for patients with late-onset hypogonadism: An open-label, randomized, crossover study

Tsukasa Narukawa  1 , Jintetsu Soh  1 , Noriyuki Kanemitsu  1 , Shunji Harikai  1 , Atsuko Fujihara  1 , Osamu Ukimura  1
Affiliations
Randomized Controlled Trial

Efficacy of testosterone replacement therapy plus alternate-day tadalafil for patients with late-onset hypogonadism: An open-label, randomized, crossover study

Tsukasa Narukawa et al. Int J Urol. 2021 Apr.

Abstract

Objective: To examine the efficacy and safety of combination treatment with testosterone replacement therapy plus alternate-day tadalafil (10 mg) in patients with late-onset hypogonadism.

Methods: In this open-label, randomized, crossover study, 29 patients with late-onset hypogonadism were randomly assigned to receive testosterone replacement therapy for 12 weeks followed by combination treatment for 12 weeks (Group 1) or combination treatment for 12 weeks followed by testosterone replacement therapy (Group 2). Symptom questionnaires were administered and blood tests were performed prior to and following each treatment to assess safety and efficacy. At the end of the study, participants were asked about their treatment preferences.

Results: An adverse effect, a rheum symptom, occurred in only one participant, and 26 participants completed the study without any toxicity. Scores on the Aging Male Symptoms scale and the modified short version of the International Index of Erectile Function, and Overactive Bladder Symptom scores were significantly improved in the combination treatment phase of Group 2, whereas no significant difference between the phases were observed in Group 1. In total, 12 out of the 14 participants in Group 1 and 11 out of the 12 participants in Group 2 preferred combination treatment, which reached statistical significance (P = 0.008 and 0.004 for Groups 1 and 2, respectively).

Conclusions: Testosterone replacement therapy with add-on alternate-day tadalafil is a safe and satisfactory treatment for patients with late-onset hypogonadism.

Keywords: combination treatment; hypogonadism; intramuscular injection; tadalafil; testosterone.

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