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

April 14, 2019 updated by: Nobelpharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

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

Genders Eligible for Study

Female

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-16 Standard Dosing Regimen Group
Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
Drug: NPC-16 Standard Dosing Regimen Group
Other Names:
  • Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
Experimental: NPC-16 Continuous Dosing Regimen Group
Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
Drug: NPC-16 Continuous Dosing Regimen Group
Other Names:
  • Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
Placebo Comparator: Placebo Group
Placebo for NPC-16
Drug: Placebo Group
Other Names:
  • Placebo for NPC-16

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Nobelpharma

Investigators

  • Study Chair: Tasuku Harada, MD, PhD, Tottori University
  • Study Chair: Mikio Momoeda, MD, PhD, St. Luke's International Hospital

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 (Actual)

February 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 28, 2017

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimate)

February 13, 2015

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 14, 2019

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-16-2

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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