Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea

Phase 3 Completed 115 enrolled Nobelpharma

RandomizedParallel-groupTriple-blindTreatment

Summary

The 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.

Timeline

Start: 2008-09
Primary completion: 2009-09
Completion: 2009-09

Outcome

Met primary endpoint

paper Reduction in total dysmenorrhea score and VAS before and after treatment was significantly higher in the IKH-01 group than in the placebo group. PMID 21420678 ↗

Publications

Results Harada T, Momoeda M, Terakawa N, Taketani Y, Hoshiai H. Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2011 May;95(6):1928-31. doi: 10.1016/j.fertnstert.2011.02.045. Epub 2011 Mar 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Norethindrone	Unknown	1 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.035 mg	Oral