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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00902746
First received: May 7, 2009
Last updated: April 26, 2012
Last verified: April 2012

May 7, 2009
April 26, 2012
May 2009
February 2012   (final data collection date for primary outcome measure)
patient response to treatment for dysmenorrhea, as evaluated by verbal rating scale (VRS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00902746 on ClinicalTrials.gov Archive Site
change in the visual analog scale (VAS) of dysmenorrhea [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dysmenorrhea
Drug: NPC-01
Norethindrone, Ethinyl Estradiol
Experimental: NPC-01
Intervention: Drug: NPC-01
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • dysmenorrhea associated with endometriosis

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00902746
NPC-01-1
Yes
Nobelpharma
Nobelpharma
Not Provided
Study Director: Naoki Terakawa, M.D.,Ph.D. Nissay Hospital,Osaka,Japan
Nobelpharma
April 2012

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