Sustained benefits of leuprolide acetate with or without subsequent medroxyprogesterone acetate in the nonsurgical management of leiomyomata uteri.

OBJECTIVE

To determine the effectiveness of leuprolide acetate (LA) followed by medroxyprogesterone acetate (MPA) in the treatment of abnormal uterine bleeding attributed to leiomyomata uteri.

DESIGN

Randomized, double-blinded, controlled clinical trial.

SETTING

Human volunteers in an academic research environment.

PATIENTS

Premenopausal women with abnormal uterine bleeding attributed to leiomyomata uteri.

INTERVENTIONS

Subjects received 6 months of LA after which they were randomized to receive MPA or placebo.

MAIN OUTCOME MEASURES

Control of bleeding as assessed by menstrual calendar and self-report; hematologic parameters (hemoglobin and ferritin); uterine size by ultrasonography.

RESULTS

More than three quarters of subjects became amenorrheic on LA. The proportion of subjects with improvement in the bleeding abnormality after therapy was not different in the group receiving MPA compared with placebo; however, women who received MPA were less likely to be anemic after therapy than women receiving placebo. Among the women assigned to placebo, 55% experienced an improvement in bleeding compared with pre-GnRH agonist therapy that persisted after discontinuation of LA. There was a high dropout rate (51%), largely associated with failure of the regimens to control bleeding symptoms.

CONCLUSIONS

Approximately one half of women with abnormal bleeding attributed to leiomyomata uteri have sustained symptomatic improvement after 6 months of therapy with LA even when only placebo therapy is given, although MPA decreases the incidence of anemia. Leuprolide acetate with or without subsequent progestin may be useful as a component of nonsurgical management of these tumors, with monitoring of hematologic status. The interpretability of these data is limited by the high rate of therapy discontinuation in women with abnormal bleeding of the severity studied here.