Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis

Phase 3

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: NPC-01

• Registration Number: NCT00902746
• Lead Sponsor: Nobelpharma

Brief Summary

The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2014-04-10
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-15
• Last Update Submitted: 2014-05-15
• Results First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

Inclusion Criteria

• Dysmenorrhea associated with endometriosis

Exclusion Criteria

• Severe hepatopathy
• Pregnant woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NPC-01	NPC-01	Norethisterone, Ethinyl Estradiol

Primary Outcome Measures

Name	Time	Method
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)	52 weeks	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 Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)	52 weeks	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.