Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

Last updated: February 18, 2025
Sponsor: Nobelpharma
Overall Status: Completed

Phase

3

Condition

Menstrual Disorders

Severe Premenstrual Symptom

Female Hormonal Deficiencies/abnormalities

Treatment

NPC-01

Placebo

IKH-01

Clinical Study ID

NCT01129102
NPC-01-2
  • Ages > 16
  • Female

Study Summary

The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • dysmenorrhea

Exclusion

Exclusion Criteria:

  • severe hepatopathy

  • pregnant woman

Study Design

Total Participants: 215
Treatment Group(s): 3
Primary Treatment: NPC-01
Phase: 3
Study Start date:
May 01, 2010
Estimated Completion Date:
April 30, 2011

Study Description

The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).

Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.

To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).