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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00902746
Recruitment Status : Completed
First Posted : May 15, 2009
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Information provided by (Responsible Party):

May 7, 2009
May 15, 2009
April 10, 2014
June 13, 2014
June 13, 2014
May 2009
February 2012   (Final data collection date for primary outcome measure)
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) [ Time Frame: 52 weeks ]

The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work

Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days

patient response to treatment for dysmenorrhea, as evaluated by verbal rating scale (VRS) [ Time Frame: 52 weeks ]
Complete list of historical versions of study NCT00902746 on Archive Site
Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) [ Time Frame: 52 weeks ]
VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.
change in the visual analog scale (VAS) of dysmenorrhea [ Time Frame: 52 weeks ]
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Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis
Phase3, Open-Label, Long-Term, NSAID-Add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea Associated With Endometriosis.
The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.
Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Experimental: NPC-01
Norethisterone, Ethinyl Estradiol
Intervention: Drug: NPC-01
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Dysmenorrhea associated with endometriosis

Exclusion Criteria:

  • Severe hepatopathy
  • Pregnant woman
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Naoki Terakawa, M.D.,Ph.D. Nissay Hospital,Osaka,Japan
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP