Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial.

Author(s): Harada T, Momoeda M, Terakawa N, Taketani Y, Hoshiai H.

Affiliation(s): Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago, Japan. tasuku@grape.med.tottori-u.ac.jp

Publication date & source: 2011, Fertil Steril. , 95(6):1928-31

OBJECTIVE: To evaluate the efficacy and safety of low-dose oral contraceptives (IKH-01; 0.035 mg ethinyl estradiol and 1 mg norethisterone) for patients with primary dysmenorrhea. DESIGN: Placebo-controlled, double-blind, randomized trial. SETTING: Clinical trial sites in Japan. PATIENT(S): One hundred fifteen patients with primary dysmenorrhea. INTERVENTION(S): Patients randomly assigned to receive IKH-01 or placebo for four cycles. MAIN OUTCOME MEASURE(S): Total dysmenorrhea score, verbal rating scale defining pain according to limited ability to work and need for analgesics, and visual analog scale (VAS). RESULT(S): Reduction in total dysmenorrhea score and VAS before and after treatment was significantly higher in the IKH-01 group than in the placebo group. Total dysmenorrhea score and VAS in the IKH-01 group significantly decreased from cycles 2 to 5. Overall incidence of adverse events was significantly higher in the IKH-01 group. Incidence decreased over time in the IKH-01 group; it was invariable in the placebo group. No serious adverse events occurred. CONCLUSION(S): IKH-01 could be used as a single agent or in combination with analgesics for treatment of primary dysmenorrhea.