NCT01129102

Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Nobelpharma · Industry
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	NPC-01	Norethisterone 1mg, Ethinyl estradiol 0.02mg
DRUG	IKH-01	Norethisterone 1mg, Ethinyl estradiol 0.035mg
DRUG	Placebo	Placebo for NPC-01

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-05-24
• Last updated: 2025-03-05
• Results posted: 2014-06-17