Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea

Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02362711

Enrollment

248

Registered

2015-02-13

Start date

2015-02-28

Completion date

2017-01-28

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea

Brief summary

The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.

Interventions

DRUGNPC-16 Standard Dosing Regimen Group

DRUGNPC-16 Continuous Dosing Regimen Group

DRUGPlacebo Group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* dysmenorrhea

Exclusion criteria

* severe hepatopathy * pregnant woman

Design outcomes

Primary

Measure	Time frame
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score	52 weeks

Secondary

Measure	Time frame
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea	52 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026