A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia

Summary

This clinical interventional study aims to assess whether treatment with with leflutrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian hormone (AMH) or Inhibin B as a positive predictive biomarker.

Timeline

Start

2026-05-01

Primary completion

2027-05-31

Completion

2027-08-31

Publications

• Background Pundir J, Achilli C, Bhide P, Sabatini L, Legro RS, Rombauts L, Teede H, Coomarasamy A, Zamora J, Thangaratinam S. Risk of foetal harm with letrozole use in fertility treatment: a systematic review and meta-analysis. Hum Reprod Update. 2021 Apr 21;27(3):474-485. doi: 10.1093/humupd/dmaa055.
• Background Wickramasinghe LC, Tsantikos E, Kindt A, Raftery AL, Gottschalk TA, Borger JG, Malhotra A, Anderson GP, van Wijngaarden P, Hilgendorff A, Hibbs ML. Granulocyte Colony-Stimulating Factor is a Determinant of Severe Bronchopulmonary Dysplasia and Coincident Retinopathy. Am J Pathol. 2023 Dec;193(12):2001-2016. doi: 10.1016/j.ajpath.2023.07.006. Epub 2023 Sep 9.
• Background Yang Y, Chen S, Chen H, Guo Y, Teng X. The efficacy of anastrozole in subfertile men with and without abnormal testosterone to estradiol ratios. Transl Androl Urol. 2022 Sep;11(9):1262-1270. doi: 10.21037/tau-22-95.
• Background Cavallini G, Beretta G, Biagiotti G. Preliminary study of letrozole use for improving spermatogenesis in non-obstructive azoospermia patients with normal serum FSH. Asian J Androl. 2011 Nov;13(6):895-7. doi: 10.1038/aja.2011.44. Epub 2011 Jun 27.
• Background Helo S, Ellen J, Mechlin C, Feustel P, Grossman M, Ditkoff E, McCullough A. A Randomized Prospective Double-Blind Comparison Trial of Clomiphene Citrate and Anastrozole in Raising Testosterone in Hypogonadal Infertile Men. J Sex Med. 2015 Aug;12(8):1761-9. doi: 10.1111/jsm.12944. Epub 2015 Jul 14.
• Background Eisenberg ML, Lathi RB, Baker VL, Westphal LM, Milki AA, Nangia AK. Frequency of the male infertility evaluation: data from the national survey of family growth. J Urol. 2013 Mar;189(3):1030-4. doi: 10.1016/j.juro.2012.08.239. Epub 2012 Sep 23.
• Background Schlegel PN, Sigman M, Collura B, De Jonge CJ, Eisenberg ML, Lamb DJ, Mulhall JP, Niederberger C, Sandlow JI, Sokol RZ, Spandorfer SD, Tanrikut C, Treadwell JR, Oristaglio JT, Zini A. Diagnosis and treatment of infertility in men: AUA/ASRM guideline part II. Fertil Steril. 2021 Jan;115(1):62-69. doi: 10.1016/j.fertnstert.2020.11.016. Epub 2020 Dec 9.
• Background Agarwal A, Mulgund A, Hamada A, Chyatte MR. A unique view on male infertility around the globe. Reprod Biol Endocrinol. 2015 Apr 26;13:37. doi: 10.1186/s12958-015-0032-1.
• Background Thonneau P, Marchand S, Tallec A, Ferial ML, Ducot B, Lansac J, Lopes P, Tabaste JM, Spira A. Incidence and main causes of infertility in a resident population (1,850,000) of three French regions (1988-1989). Hum Reprod. 1991 Jul;6(6):811-6. doi: 10.1093/oxfordjournals.humrep.a137433.

Drugs

Indications