Title

Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea
Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    npc-16 ...
  • Study Participants

    248
The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.
Study Started
Feb 28
2015
Primary Completion
Jan 31
2017
Study Completion
Jan 28
2017
Last Update
Apr 16
2019

Drug NPC-16 Standard Dosing Regimen Group

  • Other names: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Drug NPC-16 Continuous Dosing Regimen Group

  • Other names: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Drug Placebo Group

  • Other names: Placebo for NPC-16

NPC-16 Standard Dosing Regimen Group Experimental

Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

NPC-16 Continuous Dosing Regimen Group Experimental

Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Placebo Group Placebo Comparator

Placebo for NPC-16

Criteria

Inclusion Criteria:

dysmenorrhea

Exclusion Criteria:

severe hepatopathy
pregnant woman
No Results Posted