Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.

Detailed Description
-----------------
The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea). Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them. To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).

Official Title
-----------------
Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: NPC-01
* Drug: IKH-01
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dysmenorrhea Exclusion Criteria: severe hepatopathy pregnant woman

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPC-01<br>Norethisterone 1mg, Ethinyl estradiol 0.02mg | Drug: NPC-01<br>* Norethisterone 1mg, Ethinyl estradiol 0.02mg<br>|
| Active Comparator: IKH-01<br>Norethisterone 1mg, Ethinyl estradiol 0.035mg | Drug: IKH-01<br>* Norethisterone 1mg, Ethinyl estradiol 0.035mg<br>|
| Placebo Comparator: Placebo<br>Placebo for NPC-01 | Drug: Placebo<br>* Placebo for NPC-01<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days | 16weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain. | 16weeks |