Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea

Phase 3

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: NPC-16 Standard Dosing Regimen Group; Drug: NPC-16 Continuous Dosing Regimen Group; Drug: Placebo Group

• Registration Number: NCT02362711
• Lead Sponsor: Nobelpharma

Brief Summary

The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-02
• Study Start: 2015-02
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Primary Completion: 2017-01
• Study Completion: 2017-01-28
• Last Update Submitted: 2019-04-14
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 248

Inclusion Criteria

• dysmenorrhea

Exclusion Criteria

• severe hepatopathy
• pregnant woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPC-16 Standard Dosing Regimen Group	NPC-16 Standard Dosing Regimen Group	Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
NPC-16 Continuous Dosing Regimen Group	NPC-16 Continuous Dosing Regimen Group	Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
Placebo Group	Placebo Group	Placebo for NPC-16

Primary Outcome Measures

Name	Time	Method
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score	52 weeks

Secondary Outcome Measures

Name	Time	Method
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea	52 weeks