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Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

NCT01129102 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-03-05

Study results available
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Summary

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

Conditions

  • Dysmenorrhea

Interventions

DRUG

NPC-01

Norethisterone 1mg, Ethinyl estradiol 0.02mg

DRUG

IKH-01

Norethisterone 1mg, Ethinyl estradiol 0.035mg

DRUG

Placebo

Placebo for NPC-01

Sponsors & Collaborators

  • Nobelpharma

    lead INDUSTRY

Principal Investigators

  • Naoki Terakawa, M.D.,Ph.D. · Nissay Hospital,Osaka,Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-04-30
Completion
2011-04-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129102 on ClinicalTrials.gov