Clinical Trial Name - Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis
| Original Study ID : NPC-01-1 |
| NCT ID : NCT00902746 |
| Brief Title : Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis |
| Official Title : Phase3, Open-Label, Long-Term, NSAID-Add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea Associated With Endometriosis. |
| Brief Summary :
The purpose of this long-term study is to determine whether NPC-01 is effective in the
treatment of dysmenorrhea associated with endometriosis.
|
| Source : Nobelpharma |
| Overall Status : Not yet recruiting |
| Start Date : May 2009 |
| End Date : May 2011 |
| Completion Date : May 2011 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Enrollment : 140 |
| Verification Date : May 2009 |
| First Received Date : May 7, 2009 |
| Trial Eligibility |
Criteria :
Inclusion Criteria:
- dysmenorrhea associated with endometriosis
Exclusion Criteria:
- severe hepatopathy
- pregnant woman
|
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| OutComes |
| Primary OutComes |
| Measure : patient response to treatment for dysmenorrhea, as evaluated by verbal rating scale (VRS) |
| Time Frame : 52 weeks |
| Safety issue : No |
|
| Secondary OutComes |
| Measure : change in the visual analog scale (VAS) of dysmenorrhea |
| Time Frame : 52 weeks |
| Safety issue : No |
|
| Interventions |
| Type : Drug |
| Name : NPC-01 |
| Description : Norethindrone, Ethinyl Estradiol |
|
