Treatment with nafarelin for endometriosis in young women - Efficacy, safety and lipid metabolism

OBJECTIVE: To assess the efficacy, safety and effect on lipid metabolism of treatment with nafarelin acetate for clinical endometriosis symptoms in yo ung women. STUDY DESIGN: A multicenter, open-label, nonrandomized clinical trial was c onducted on subjects who were 19-29 years of age with clinical symptoms and signs of endometriosis demonstrated by laparoscopy, ultrasonography, magne tic resonance imaging, computed tomography or pelvic examination. For 24 we eks, 34 women received intranasal nafarel, 200 mg twice daily. The main out come measures were changes in signs and symptoms, lumbar bone mineral densi ty by dual energy X-ray absorptiometry and serum parameters of lipid metabo lism. RESULTS: Symptoms and signs of endometriosis decreased significantly during treatment and at the first posttreatment menses. CA-125 level decreased si gnificantly, from 84.0 +/- 20.2 U/mL at baseline to 13.4 +/- 1.9 at the 24t h week (P=.0014). The mean high density lipoprotein cholesterol, total chol esterol, apoprotein A-I and A-II, lipoprotein (a) and remnant lipoprotein c holesterol levels significantly increased, and cholesterol ester transfer p rotein activity slightly increased, by the 24th week but fell to baseline v alues by the first posttreatment menses. Despite a low mean serum estradiol level (20 pg/mL) at the end of treatment, the reported incidence of hot fl ushes was low (24%), and only one woman withdrew because of hypoestrogenic CONCLUSION: Twenty-four-week nafarelin treatment for clinical endometriosis symptoms in women less than or equal to 29 years was safe and effective.