NEW YORK (Reuters Health) - Letrozole used in combination with norethindrone acetate appears to be an effective treatment for refractory endometriosis in reproductive-age women, according to findings from a small pilot study.
“This study demonstrates the potential of aromatase inhibitors to significantly and rapidly reduce disease severity and pain, offering women a new and more effective way of suppressing endometriosis with fewer side effects,” senior author Dr. Serdar Bulun, from Northwestern University Medical School in Chicago, said in a statement.
The findings of the phase II trial, which are reported in the February issue of Fertility and Sterility, are based on a study of 10 premenopausal women with endometriosis-related pain that was refractory to previous treatment modalities.
The patients were treated with letrozole 2.5 mg, norethindrone acetate 2.5 mg, calcium citrate 1250 mg, and vitamin D 800 IU daily for 6 months. A few weeks before and after the treatment period, diagnostic laparoscopy was performed to grade the degree of endometriosis.
At follow-up, all of the patients had experienced a dramatic reduction in laparoscopically visible and histologic confirmed endometriosis. With the exception of one patient whose pain scores worsened during treatment, all of the patients reported significant pain relief. No significant changes in bone density, gonadotropin levels, or levels of estradiol and estrone were noted during the study.
“These results appear extremely promising and constitute the rationale for further investigation of this regimen as a first-line treatment for endometriosis,” Dr. Bulun noted.
The study was funded by a grant from drug maker Novartis, which markets letrozole as a treatment for advanced breast cancer under the name Femara.
Fertil Steril;February 2004.
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