Treatment with nafarelin for endometriosis in young women. Efficacy, safety and lipid metabolism. Niigata Nafarelin Study Group.

OBJECTIVE

To assess the efficacy, safety and effect on lipid metabolism of treatment with nafarelin acetate for clinical endometriosis symptoms in young women.

STUDY DESIGN

A multicenter, open-label, nonrandomized clinical trial was conducted on subjects who were 19-29 years of age with clinical symptoms and signs of endometriosis demonstrated by laparoscopy, ultrasonography, magnetic resonance imaging, computed tomography or pelvic examination. For 24 weeks, 34 women received intranasal nafarel, 200 mg twice daily. The main outcome measures were changes in signs and symptoms, lumbar bone mineral density by dual energy X-ray absorptiometry and serum parameters of lipid metabolism.

RESULTS

Symptoms and signs of endometriosis decreased significantly during treatment and at the first posttreatment menses. CA-125 level decreased significantly, from 84.0 +/- 20.2 U/mL at baseline to 13.4 +/- 1.9 at the 24th week (P = .0014). The mean high density lipoprotein cholesterol, total cholesterol, apoprotein A-I and A-II, lipoprotein (a) and remnant lipoprotein cholesterol levels significantly increased, and cholesterol ester transfer protein activity slightly increased, by the 24th week but fell to baseline values 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 flushes was low (24%), and only one woman withdrew because of hypoestrogenic symptoms.

CONCLUSION

Twenty-four-week nafarelin treatment for clinical endometriosis symptoms in women < or = 29 years was safe and effective.