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

Phase 3

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: IKH-01; Drug: Placebo

• Registration Number: NCT00746096
• Lead Sponsor: Nobelpharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-29
• Study Start: 2008-09
• Study First Submitted QC: 2008-09-01
• Study First Posted: 2008-09-03
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2014-04-08
• Results First Submitted QC: 2014-05-15
• Results First Posted: 2014-06-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

Inclusion Criteria

• primary dysmenorrhea

Exclusion Criteria

• severe hepatopathy
• pregnant woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IKH-01	IKH-01	ethinyl estradiol 0.035mg and norethisterone 1mg
Placebo	Placebo	Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

Primary Outcome Measures

Name	Time	Method
Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)	16weeks	The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work; Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days

Secondary Outcome Measures

Name	Time	Method
Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)	16weeks	VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.