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

NCT ID: NCT00746096

Last Updated: 2025-03-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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IKH-01

ethinyl estradiol 0.035mg and norethisterone 1mg

Group Type EXPERIMENTAL

IKH-01

Intervention Type DRUG

ethinyl estradiol 0.035mg and norethisterone 1mg

Placebo

Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

Interventions

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IKH-01

ethinyl estradiol 0.035mg and norethisterone 1mg

Intervention Type DRUG

Placebo

Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* primary dysmenorrhea

Exclusion Criteria

* severe hepatopathy
* pregnant woman
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nobelpharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naoki Terakawa, M.D.,Ph.D.

Role: STUDY_DIRECTOR

Nissay Hospital,Osaka,Japan

References

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Harada T, Momoeda M, Terakawa N, Taketani Y, Hoshiai H. Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2011 May;95(6):1928-31. doi: 10.1016/j.fertnstert.2011.02.045. Epub 2011 Mar 21.

Reference Type RESULT
PMID: 21420678 (View on PubMed)

Other Identifiers

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IKH-01-6

Identifier Type: -

Identifier Source: org_study_id

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