Objective: To compare the efficacy of a triphasic combination oral contraceptive (OC) containing norgestimate and ethinyl estradiol (E2) and placebo in the treatment of metrorrhagic, menometrorrhagic, oligomenorrheic, and polymenorrheic dysfunctional uterine bleeding (DUB).
Methods: In this multicenter, randomized, double-masked study, 201 women (15-50 years of age) with DUB received triphasic norgestimate-ethinyl E2 or placebo, for three consecutive 28-day treatment 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 subjects' quality of life. The sample size was based on the assumption that the proportions of subjects exhibiting treatment success (percentage of subjects with investigator and subject overall assessments of DUB 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 investigators, and the subjects themselves compared with fewer than 50% of subjects in the placebo treatment group (P <.001). Abnormal bleeding patterns were reported by significantly fewer subjects receiving triphasic norgestimate-ethinyl E2 than in the placebo treatment group (P <. 001). Change from baseline in physical functioning (eg, self-care, walking, lifting, exercising) 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, and polymenorrheic dysfunctional uterine bleeding.