Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis

PHASE3CompletedINTERVENTIONAL
Enrollment

149

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Dysmenorrhea
Interventions
DRUG

NPC-01

"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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nobelpharma

INDUSTRY

NCT00902746 - Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis | Biotech Hunter | Biotech Hunter