CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 149 enrolled
Drug / intervention
NPC-01drug
Likely dose
NPC-01 0.6mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00902746
NCT00902746Phase 3Completed
CompareCT.gov

Phase3, Open-Label, Long-Term, NSAID-Add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea Associated With Endometriosis.

Nobelpharma·interventional·Posted May 15, 2009·Updated Jun 15, 2025

In Brief

A Phase 3 clinical trial evaluating NPC-01 for Dysmenorrhea. Completed, enrolled 149 participants.

Detailed Summary

The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysmenorrhea
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2009
Enrollment StartMay 1, 2009
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.1 years ago

Interventions

NPC-01drug

This study consist of the following steps. Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles. Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg): After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point.