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

NCT ID: NCT02362711

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-01-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysmenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NPC-16 Standard Dosing Regimen Group

Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Group Type EXPERIMENTAL

NPC-16 Standard Dosing Regimen Group

Intervention Type DRUG

NPC-16 Continuous Dosing Regimen Group

Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Group Type EXPERIMENTAL

NPC-16 Continuous Dosing Regimen Group

Intervention Type DRUG

Placebo Group

Placebo for NPC-16

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NPC-16 Standard Dosing Regimen Group

Intervention Type DRUG

NPC-16 Continuous Dosing Regimen Group

Intervention Type DRUG

Placebo Group

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg Placebo for NPC-16

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* dysmenorrhea

Exclusion Criteria

* severe hepatopathy
* pregnant woman
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nobelpharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tasuku Harada, MD, PhD

Role: STUDY_CHAIR

Tottori University

Mikio Momoeda, MD, PhD

Role: STUDY_CHAIR

St. Luke's International Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NPC-16-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Drotaverine in Dysmenorrhoea Treatment
NCT00292747 TERMINATED PHASE4
The Copenhagen Analgesic Study
NCT04369222 COMPLETED