Title
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.
Phase
Phase 3Lead Sponsor
Nobel PharmaceuticalsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
DysmenorrheaIntervention/Treatment
ethinyl estradiol norethindrone ...Study Participants
115The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.
ethinyl estradiol 0.035mg and norethisterone 1mg
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Inclusion Criteria: primary dysmenorrhea Exclusion Criteria: severe hepatopathy pregnant woman
| Event Type | Organ System | Event Term | IKH-01 | Placebo |
|---|
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
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.
