Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

Brief Summary

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

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Detailed Description

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The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).

Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.

To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).

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 Investigators Outcome Assessors

Study Groups

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NPC-01

Norethisterone 1mg, Ethinyl estradiol 0.02mg

Group Type EXPERIMENTAL

NPC-01

Intervention Type DRUG

Norethisterone 1mg, Ethinyl estradiol 0.02mg

IKH-01

Norethisterone 1mg, Ethinyl estradiol 0.035mg

Group Type ACTIVE_COMPARATOR

IKH-01

Intervention Type DRUG

Norethisterone 1mg, Ethinyl estradiol 0.035mg

Placebo

Placebo for NPC-01

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for NPC-01

Interventions

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NPC-01

Norethisterone 1mg, Ethinyl estradiol 0.02mg

Intervention Type DRUG

IKH-01

Norethisterone 1mg, Ethinyl estradiol 0.035mg

Intervention Type DRUG

Placebo

Placebo for NPC-01

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* dysmenorrhea

Exclusion Criteria

* severe hepatopathy
* pregnant woman

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

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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Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.

Reference Type DERIVED

PMID: 37523477 (View on PubMed)

Harada T, Momoeda M. Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2016 Dec;106(7):1807-1814. doi: 10.1016/j.fertnstert.2016.08.051. Epub 2016 Oct 4.

Reference Type DERIVED

PMID: 27717552 (View on PubMed)

Other Identifiers

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NPC-01-2

Identifier Type: -

Identifier Source: org_study_id

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Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

Study Results

Basic Information

Brief Summary

Related Clinical Trials

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Treatment of Primary Menstrual Pain With Kanion Capsule

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Detailed Description

Conditions

Study Design

Study Groups

NPC-01

NPC-01

IKH-01

IKH-01

Placebo

Placebo

Interventions

NPC-01

IKH-01

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Nobelpharma

Responsible Party

Principal Investigators

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

References

Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.

Harada T, Momoeda M. Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2016 Dec;106(7):1807-1814. doi: 10.1016/j.fertnstert.2016.08.051. Epub 2016 Oct 4.

Other Identifiers

NPC-01-2

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