Tasuku Harada1, Mikio Momoeda2. 1. Department of Obstetrics and Gynecology, Tottori University School of Medicine, Tottori, Japan. Electronic address: tasuku@grape.med.tottori-u.ac.jp. 2. Department of Integrated Women's Health, St. Luke's International Hospital, Tokyo, Japan.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea. DESIGN:Placebo-controlled, double-blind, randomized trial. SETTING: Clinical trial sites. PATIENT(S): Two hundred fifteen subjects with dysmenorrhea. INTERVENTION(S): Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles. MAIN OUTCOME MEASURE(S): Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics. RESULT(S): The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred. CONCLUSION(S): The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01129102.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea. DESIGN: Placebo-controlled, double-blind, randomized trial. SETTING: Clinical trial sites. PATIENT(S): Two hundred fifteen subjects with dysmenorrhea. INTERVENTION(S): Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles. MAIN OUTCOME MEASURE(S): Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics. RESULT(S): The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred. CONCLUSION(S): The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01129102.