Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

February 18, 2025 updated by: Nobelpharma

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

The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • dysmenorrhea

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

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)
Time Frame: 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
16weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)
Time Frame: 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.
16weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nobelpharma

Investigators

  • Study Director: Naoki Terakawa, M.D.,Ph.D., Nissay Hospital,Osaka,Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimated)

May 24, 2010

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-01-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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