Regression of uterine leiomyomas after treatment with gestrinone, an antiestrogen, antiprogesterone

Ninety-seven women, aged 18 to 53 years, with uterine leiomyomas diagnosed by bimanual palpation and ultrasonography, were treated for 4 to 13 months with gestrinone, a potent steroidal, antiestrogen, antiprogesterone. Thirteen women were less than 30 years old and six 50 years old or older. Forty-six women were 30 to 40 years old and 32 others were 40 to 50 years old. Sixty-one women were nulliparous. Patients were divided in a random fashion into three groups according to treatment schedule. In group A, 34 patients received capsules containing 5 mg of gestrinone twice weekly. In group B, 36 patients received 2.5 mg capsules three times weekly. In group C, 27 patients were instructed to insert 2.5 mg tablets in the vagina three times weekly. Uterine volume was measured by ultrasonography before and at the end of treatment. At the end of 4 months, uterine volume fell from 303 to 251 cm3 in group A, from 361 to 266 cm3 in group B, but increased from 371 to 387 cm3 in group C. For those patients treated for 10 (+/- 1) months, mean uterine volume fell from 368 to 282 cm3 in group A and from 384 to 327 cm3 in group B, but increased from 262 to 290 cm3 in group C. Mean uterine volume of patients who were treated for 13 (+/- 1) months also fell from 325 to 259 cm3 in group A, from 416 to 268 cm3 in group B, and from 406 to 399 cm3 in group C. Changes in uterine volume measured at the time of discontinuation for the various groups revealed volume decrease in 71 and increase or no change in 26. Differences between groups A, B, and C were statistically significant when comparisons were made at 4 and 13 months. Uterine bleeding ceased by the second month of treatment in half the patients initially complaining of menometrorrhagias. After 4 months of treatment, 95% of the women were amenorrheic. Hemoglobin increased in 85 of 90 patients for whom values were available before treatment began. Both dyspareunia and chronic pain were significantly reduced by the gestrinone treatment. Androgenic side effects such as seborrhea, acne, and hirsutism, whenever they occurred, were benign and reverted soon after discontinuing the medication.