NCT02362711

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2017

Completed
Last Updated

April 16, 2019

Status Verified

February 1, 2015

Enrollment Period

1.9 years

First QC Date

February 9, 2015

Last Update Submit

April 14, 2019

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score

    52 weeks

Secondary Outcomes (1)

  • Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea

    52 weeks

Study Arms (3)

NPC-16 Standard Dosing Regimen Group

EXPERIMENTAL

Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Drug: NPC-16 Standard Dosing Regimen Group

NPC-16 Continuous Dosing Regimen Group

EXPERIMENTAL

Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Drug: NPC-16 Continuous Dosing Regimen Group

Placebo Group

PLACEBO COMPARATOR

Placebo for NPC-16

Drug: Placebo Group

Interventions

NPC-16 Standard Dosing Regimen GroupDRUG
Also known as: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
NPC-16 Standard Dosing Regimen Group
NPC-16 Continuous Dosing Regimen GroupDRUG
Also known as: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
NPC-16 Continuous Dosing Regimen Group
Placebo GroupDRUG
Also known as: Placebo for NPC-16
Placebo Group

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • dysmenorrhea

You may not qualify if:

  • severe hepatopathy
  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysmenorrhea

Interventions

LevonorgestrelEthinyl EstradiolNPC 16

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Tasuku Harada, MD, PhD

    Tottori University

    STUDY CHAIR

  • Mikio Momoeda, MD, PhD

    St. Luke's International Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 28, 2017

Last Updated

April 16, 2019

Record last verified: 2015-02