Evaluation of the efficacy and safety of dienogest in the treatment of painful symptoms in patients with adenomyosis: A randomized, double-blind, multicenter, placebo-controlled study

Fertility and Sterility | September 13, 2017

Osuga Y, et al. - A randomized, double-blind, multicenter, placebo-controlled study is performed to assess the effectiveness and safety of dienogest (DNG), a progestational 19-norsteroid, in patients with symptomatic adenomyosis. These outcomes propose that DNG is effective and well tolerated in the treatment for painful symptoms related to adenomyosis not complicated by severe uterine enlargement or severe anemia.

Methods

  • For this research, they designed a phase III, randomized, double-blind, multicenter, placebo-controlled study.
  • This study was conducted at clinical study sites in Japan.
  • Total sixty-seven patients with adenomyosis were selected for this study.
  • In this study, patients were randomly assigned to receive DNG (2 mg/d, orally) or placebo for 16 weeks.
  • In this study, patients were treated for anemia before randomization, in cases of complicated anemia.

Results

  • In this study, they observed that the pain score was decreased from baseline.
  • The visual analogue scale at the end of treatment were significantly more in the DNG group than in the placebo group (P<.001).
  • Amid the treatment period, almost all of the patients treated with DNG experienced irregular uterine bleeding and one patient had mild anemia.
  • There were no severe cases of anemia.

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