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

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Dysmenorrhea

Treatments: Drug: Placebo; Drug: IKH-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT00746096

IKH-01-6

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary 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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115 participants in 2 patient groups, including a placebo group

IKH-01

Experimental group

Description:

ethinyl estradiol 0.035mg and norethisterone 1mg

Treatment:

Drug: IKH-01

Placebo

Placebo Comparator group

Description:

Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

Treatment:

Drug: Placebo