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

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Dysmenorrhea

Treatments: Drug: NPC-16 Continuous Dosing Regimen Group; Drug: NPC-16 Standard Dosing Regimen Group; Drug: Placebo Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT02362711

NPC-16-2

Details and patient eligibility

About

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

Enrollment: 248 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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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248 participants in 3 patient groups, including a placebo group

NPC-16 Standard Dosing Regimen Group

Experimental group

Description:

Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Treatment:

Drug: NPC-16 Standard Dosing Regimen Group

NPC-16 Continuous Dosing Regimen Group

Experimental group

Description:

Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Treatment:

Drug: NPC-16 Continuous Dosing Regimen Group

Placebo Group

Placebo Comparator group

Description:

Placebo for NPC-16

Treatment:

Drug: Placebo Group