Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

Phase 3

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: Placebo; Drug: NPC-01; Drug: IKH-01

• Registration Number: NCT01129102
• Lead Sponsor: Nobelpharma

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).

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2014-04-10
• Results First Submitted QC: 2014-05-15
• Results First Posted: 2014-06-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 215

Inclusion Criteria

• dysmenorrhea

Exclusion Criteria

• severe hepatopathy
• pregnant woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for NPC-01
NPC-01	NPC-01	Norethisterone 1mg, Ethinyl estradiol 0.02mg
IKH-01	IKH-01	Norethisterone 1mg, Ethinyl estradiol 0.035mg

Primary Outcome Measures

Name	Time	Method
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)	16weeks	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

Secondary Outcome Measures

Name	Time	Method
Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)	16weeks	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.