Triphasic norgestimate/ethinyl estradiol oral contraceptive for the treatment of dysfunctional uterine bleeding

Abstract

Objective: To compare the efficacy of a triphasic combination oral contraceptive (OC) containing norgestimate and ethinyl estradiol (Ortho Tri-Cyclen) and placebo in the treatment of metrorrhagic, menometrorrhagic, oligomenorrheic, and polymenorrheic dysfunctional uterine bleeding (DUB). To our knowledge, this study is the first report of a placebo-controlled study of an OC in the treatment of DUB.Methods: In this double-blind, placebo-controlled, multicenter trial, 201 women with DUB were randomized to norgestimate/ethinyl estradiol (NGM/EE) or placebo for 3 cycles. Efficacy was determined by evaluating investigator and subject assessments of DUB resolution, abnormal uterine bleeding patterns during an 84-day reference period, and change from baseline in quality-of-life (SF-36).Results: Subjects were on average 29.6 years of age, 72.6 kg, and had a 6.1 year history of DUB. The most frequently reported type of DUB was oligomenorrhea. Higher percentages of both investigators and subjects in the NGM/EE group (81.4% and 87.1%) compared with the placebo group (35.8% and 45.3%) assessed the subject’s condition as “improved.” These findings were similar in each of the four DUB-type subgroups. Significantly fewer subjects receiving NGM/EE than subjects receiving placebo reported abnormal bleeding patterns (P <0.001). Change from baseline in physical functioning (eg, self-care, walking, lifting, bending, exercising) was more improved in the NGM/EE group than in the placebo group (P <0.001) All other quality-of-life categories were comparable between treatment groups.Conclusion: The triphasic OC containing norgestimate and ethinyl estradiol is an effective treatment for DUB.