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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
History of Changes
  Purpose

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


Condition Intervention Phase
Dysmenorrhea
 Drug: NPC-01
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase3, Open-Label, Long-Term, NSAID-Add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea Associated With Endometriosis.

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • patient response to treatment for dysmenorrhea, as evaluated by verbal rating scale (VRS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in the visual analog scale (VAS) of dysmenorrhea [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: May 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPC-01 Drug: NPC-01
Norethindrone, Ethinyl Estradiol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dysmenorrhea associated with endometriosis

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902746

Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Naoki Terakawa, M.D.,Ph.D. Nissay Hospital,Osaka,Japan
  More Information

No publications provided

Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT00902746     History of Changes
Other Study ID Numbers: NPC-01-1
Study First Received: May 7, 2009
Last Updated: April 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dysmenorrhea
Endometriosis
Menstruation Disturbances
Pathologic Processes
 Pelvic Pain
Pain
Signs and Symptoms
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013