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Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea

NCT00746096 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-03-06

Study results available
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Summary

The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.

Conditions

  • Dysmenorrhea

Interventions

DRUG

IKH-01

ethinyl estradiol 0.035mg and norethisterone 1mg

DRUG

Placebo

Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

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
2008-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

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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 NCT00746096 on ClinicalTrials.gov