Conditions: Dysmenorrhea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 215
Healthy volunteers: no

Brief 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).

Arms:
arm 1: Norethisterone 1mg, Ethinyl estradiol 0.02mg arm 2: Norethisterone 1mg, Ethinyl estradiol 0.035mg arm 3: Placebo for NPC-01

Interventions: intervention 1: NPC-01 intervention 2: IKH-01 intervention 3: Placebo
Intervention descriptions: intervention 1: Norethisterone 1mg, Ethinyl estradiol 0.02mg intervention 2: Norethisterone 1mg, Ethinyl estradiol 0.035mg intervention 3: Placebo for NPC-01

Protocol document: