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Safety and dose-finding trial of tadalafil administered for fetus in labor: A phase I clinical study.

Yuya TamaishiHiroaki TanakaToshinori HiraiShun-Ichi HiramatsuSho TakakuraShoichi MagawaKayo TanakaEiji KondoTakuya IwamotoTomoaki Ikeda
Published in: The journal of obstetrics and gynaecology research (2024)
The study confirmed the safety of tadalafil administration during delivery for both mothers and newborns. The stable tadalafil blood levels confirmed the efficacy of the tested administration regime at 12 h interval. These findings would assist in conducting phase II trials to further verify the optimal dose and safety of tadalafil.
Keyphrases
  • phase ii
  • lower urinary tract symptoms
  • clinical trial
  • benign prostatic hyperplasia
  • open label
  • phase iii
  • pregnant women
  • study protocol
  • double blind
  • randomized controlled trial
  • preterm infants