Conditions: Dysmenorrhea
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 149
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Norethisterone, Ethinyl Estradiol

Interventions: intervention 1: NPC-01
Intervention descriptions: intervention 1: 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.

Protocol document: