Intermittent leuprolide acetate for the nonsurgical management of women with leiomyomata uteri.

OBJECTIVE

To evaluate the feasibility of intermittent 6-month courses of leuprolide acetate for the long-term control of symptoms attributed to leiomyomata uteri.

DESIGN

Prospective open-label feasibility study.

SETTING

University department of obstetrics and gynecology.

PATIENT(S): Thirty women with abnormal bleeding or discomfort (pain or pressure) due to leiomyomata uteri.

INTERVENTION(S): Patients received an initial 6-month course of the GnRH agonist leuprolide acetate, after which they were observed for symptom recurrence. Symptom recurrence was managed by repeated 6-month courses of leuprolide acetate.

MAIN OUTCOME MEASURE(S): Relief of symptoms, responses on a quality-of-life questionnaire, serum lipid levels, blood count, and ferritin level. The number of doses of leuprolide acetate required to maintain symptom control was recorded. Serial bone mineral density measurements were made in selected patients.

RESULT(S): Twenty of the 30 women who began therapy with leuprolide acetate continued in the protocol. Each individual 6-month course of leuprolide acetate therapy was followed by a median of 9 additional months of symptom control (range, 2 to >25 months). Women remaining in the protocol experienced a mean decrease of 2.4% in bone mineral density of the lumbar spine; bone mineral density of the hip did not change.

CONCLUSION(S): Intermittent courses of leuprolide acetate can be used in the nonsurgical management of women with symptomatic leiomyomata uteri. Use of antiresorptive add-back therapy and monitoring of bone mineral density can be considered when repeated courses of leuprolide acetate are given.