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

NCT00902746 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2025-06-15

Study results available
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Summary

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

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 & Collaborators

  • Nobelpharma

    lead INDUSTRY

Principal Investigators

  • Naoki Terakawa, M.D.,Ph.D. · Nissay Hospital,Osaka,Japan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-02-29
Completion
2012-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00902746 on ClinicalTrials.gov