Triphasic norgestimate-ethinyl estradiol for treating dysfunctional uterine bleeding

Objective: To compare the efficacy of a triphasic combination oral contrace ptive (OC) containing norgestimate and ethinyl estradiol (E2) and placebo i n the treatment of metrorrhagic, menometrorrhagic, oligomenorrheic, and pol ymenorrheic dysfunctional uterine bleeding (DUB). Methods: In this multicenter, randomized, double-masked study, 201 women (1 5-50 years of age) with DUE received triphasic norgestimate-ethinyl E2 or p lacebo, for three consecutive 28-day treatment cycles. Efficacy was determi ned by evaluating investigator and subject assessments of DUE resolution, a bnormal uterine bleeding patterns during an 84-day reference period, and ch ange from baseline in subjects' quality of life. The sample size was based on the assumption that the proportions of subjects exhibiting treatment suc cess (percentage of subjects with investigator and subject overall assessme nts of DUE resolution of "improved") were 65% for the active group and 40% for the placebo group (alpha = 0.05, 1 - beta = 0.80). Results: More than 80% of subjects receiving triphasic norgestimate-ethinyl E2 had improvements in their abnormal bleeding patterns as assessed by inv estigators, and the subjects themselves compared with fewer than 50% of sub jects in the placebo treatment group (P <.001). Abnormal bleeding patterns were reported by significantly fewer subjects receiving triphasic norgestim ate-ethinyl E2 than in the placebo treatment group (P <.001). Change from b aseline in physical functioning (eg, self-care, walking, lifting, exercisin g) was significantly more improved in the triphasic norgestimate-ethinyl E2 group than in the placebo group. Conclusion: The triphasic combination of norgestimate and ethinyl E2 is an effective treatment for metrorrhagic, menometrorrhagic, oligomenorrheic, an d polymenorrheic dysfunctional uterine bleeding. (Obstet Gynecol 2000;96: 9 13-20. (C) 2000 by The American College of Obstetricians and Gynecologists. ).