NAFARELIN VS LEUPROLIDE ACETATE DEPOT FOR ENDOMETRIOSIS - CHANGES IN BONE-MINERAL DENSITY AND VASOMOTOR SYMPTOMS

OBJECTIVE: To compare intranasal nafarelin and intramuscular leuprolid e acetate (LA) depot in the management of endometriosis. STUDY DESIGN: A multicenter, prospective, randomized, double-placebo, double-blind study was conducted on subjects who had symptoms and signs of endometr iosis and bane mineral density (BMD) within the age-appropriate normal range. For 6 months, 99 subjects received nafarelin, 200 mu g twice d aily, and placebo injections once monthly; 93 subjects received LA dep ot injections, 3.75 mg once monthly, and placebo nasal spray, twice da ily. Subjects were followed throughout treatment and for six months af ter treatment. The main outcome measures were changes in endometriosis symptoms and signs, BMD measurements, subject-reported and objectivel y measured hot flushes and circulating estradiol concentrations. RESUL TS: Nafarelin was as effective as LA depot in alleviating symptoms and signs of endometriosis. LA depot recipients lost significantly move B MD, had more days with subjective hot flushes and more objectively mea sured hot flushes than did nafarelin recipients. In the nafarelin grou p, estradiol levels were consistently higher than in the leuprolide de pot group, with significant differences by month 3 of dosing. CONCLUSI ON: Nafarelin and LA depot were equally effective despite higher estra diol levels in nafarelin recipients. Nafarelin-treated subjects lost l ess BMD, had fewer days with hot flushes and had fewer objectively mea sured hot flushes.