The efficacy and safety of a 19 nor-steroid in the treatment of endometriosis.

BACKGROUND

An oral synthetic 19 norsteroid (gestrinone) characterized by antigonadotropic activity and antioestrogenic properties provides its use in the treatment of oestrogen depending pathologic conditions. The purpose of this open study is to evaluate the efficacy and tolerance of gestrinone in the treatment of endometriosis.

METHODS

Twenty premenopausal women with laparoscopically confirmed endometriosis received 2.5 mg gestrinone two times per week for six months. Laparoscopy was performed before treatment, and clinical responses were determined by second laparoscopy after six months. Serum CA-125 level, plasma lipid and bone density measurements during and after therapy were compared with baseline.

RESULTS

The mean endometriosis score, defined by the revised American Fertility Society scoring system, decreased from 20.16 to 4.68 (p < 0.01). The mean serum level of CA-125 also declined from 44.04 U/ml to 18.64 U/ml (p < 0.01). Metabolic studies showed a significant decrease of cholesterol in high-density lipoprotein (p < 0.05), a moderate increase in low-density lipoprotein (p > 0.05), and a slight increase in both triglyceride and total cholesterol levels (p > 0.05). Bone density in this study also showed no significant difference in either spine or femur neck for a duration of six months treatment. Hot flush occurred in less frequency in gestrinonetreated group than in gonadotropin releasing hormone agonist (GnRHa-treated group), where the side effects of weight gain and acne were less often than in the danazol group well.

CONCLUSIONS

Gestrinone 2.5 mg given twice a week for six months provides an effective and safe treatment for those women suffering from endometriosis.