Effect of long-term naltrexone treatment on endocrine profile, clinical features, and insulin sensitivity in obese women with polycystic ovary syndrome

Objective: Evaluation of clinical and endocrine effects of naltrexone administration in obese women with PCOS, Design: Open, controlled, clinical study. Setting: Department of Reproductive Medicine and Child Development, Section of Gynecology and Obstetrics, University of Pisa, Pisa, Italy. Patient(s): Ten PCOS women were studied. Intervention(s): Women were treated with naltrexone (50 mg/day) for 6 months. Main Outcome Measure(s): Body mass index and the menstrual cyclicity during naltrexone treatment were assessed, Basal levels of LH, FSH, 17beta-estradiol (E-2), 17-hydroxyprogesterone, total and free T, androstenedione, dehydroepiandrosterone sulfate, cortisol, sex hormone-binding globulin were evaluated before treatment and every 3 months. Progesterone levels were measured in the luteal phase during the sixth month. Gonadotropin response to GnRH administration (10 mug) and a 75-g oral glucose tolerance test were performed before and every 3 months. Result(s): Body mass index significantly decreased from 29.94 +/- 1.04 to 26,07 +/- 0.81 during treatment. The menstrual cyclicity improved in 80% of PCOS women: the mean cycle length was 40-360 days before treatment and ranged between 25 and 120 days and 28-120 days after 3 and 6 months of treatment. Plasma levels of free T, androstenedione, dehydroepiandrosterone sulfate, and cortisol significantly decreased. Fasting gliucose-to-insulin ratio improved in women with insulin resistance. Conclusion(s): Naltrexone may have a beneficial effect on the clinical and endocrine-metabolic disturbances of obese PCOS women. Whether these effects are the consequences of weight loss or are due to changes in opioidergic tone is debatable. (Fertil Steril((R)) 2002-,77:936-44. (C)2002 by American Society for Reproductive Medicine).