Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Dysmenorrhea

Treatments: Drug: Placebo; Drug: IKH-01; Drug: NPC-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT01129102

NPC-01-2

Details and patient eligibility

About

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

Full description

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).

Enrollment: 215 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• dysmenorrhea

Exclusion criteria

• severe hepatopathy
• pregnant woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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215 participants in 3 patient groups, including a placebo group

NPC-01

Experimental group

Description:

Norethisterone 1mg, Ethinyl estradiol 0.02mg

Treatment:

Drug: NPC-01

IKH-01

Active Comparator group

Description:

Norethisterone 1mg, Ethinyl estradiol 0.035mg

Treatment:

Drug: IKH-01

Placebo

Placebo Comparator group

Description:

Placebo for NPC-01

Treatment:

Drug: Placebo