Phase 3
N=149
Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis
Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT00902746 ↗Enrolled (actual)
149
Serious AEs
3.4%
Results posted
Jun 2014
Primary outcome: Primary: Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) — 2.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NPC-01 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Nobelpharma
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) |
2.4 | — |
| SECONDARY Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) |
28.4 | — |
Summary
The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.
Eligibility Criteria
Inclusion Criteria
- Dysmenorrhea associated with endometriosis
Exclusion Criteria
- Severe hepatopathy
- Pregnant woman
Data sourced from ClinicalTrials.gov (NCT00902746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.