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Completed

NCT Number: NCT02362711

Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea

The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • dysmenorrhea

Exclusion criteria

  • severe hepatopathy
  • pregnant woman

Treatment and study plan

NPC-16 Standard Dosing Regimen Group

Drug

Other names: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

NPC-16 Continuous Dosing Regimen Group

Drug

Other names: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Placebo Group

Drug

Other names: Placebo for NPC-16

Primary outcomes

  1. Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score

    Time frame: 52 weeks

Secondary outcomes

  1. Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Nobelpharma

Industry

Registry information

Official study title

Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2015
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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