Effect of oral contraceptive with and without associated estriol on ultrasound measurements of breast fibroadenoma: randomized clinical trial.
OBJECTIVE
Fibroadenomas are the most common benign tumors of the female breast. The aim of this study was to evaluate the proliferative activity of breast fibroadenoma as shown by ultrasound measurements, following administration of oral contraceptives with and without associated estriol.


METHODS
This was a randomized, double-blind, placebo-controlled clinical trial carried out in the Mastology Sector, Department of Gynecology, Universidade Federal de São Paulo.


METHODS
We studied 33 women with fibroadenomas. Ten were placed in group 1 and took an oral contraceptive consisting of levonorgestrel and ethinyl estradiol together with placebo material in the same capsule, for four consecutive cycles with a seven-day interval between them. The other 23 patients constituted group 2 and took the oral contraceptive as above together with estriol in the same capsule, in the same way as done by the group 1 patients. We took ultrasound measurements of their tumors (in three dimensions) before and after the intake of medication. At the end of the study, all the patients had their tumors removed by surgery.


RESULTS
We observed decreased fibroadenoma width among the users of oral contraceptives with placebo, and this decrease was statistically significant. In the other group, we did not observe any changes (in width, length or height).


CONCLUSIONS
The results confirm that estriol may block the protective effect of oral contraceptives on fibroadenomas, since we observed decreased fibroadenoma width among the group 1 patients but not the group 2 patients.
Estevão
Rodrigo Augusto Fernandes
RA
Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil. rodrigoestevao@terra.com.br
Nazário
Afonso Celso Pinto
AC
Baracat
Edmund Chada
EC
D000328:Adult; D001706:Biopsy; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D003277:Contraceptives, Oral, Combined / Q000037:antagonists & inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004964:Estriol / Q000627:therapeutic use*; D019304:Ethinyl Estradiol-Norgestrel Combination / Q000037:antagonists & inhibitors / Q000627:therapeutic use*; D005260:Female; D018226:Fibroadenoma / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D011374:Progesterone / Q000097:blood; D018709:Statistics, Nonparametric; D014463:Ultrasonography
D003277:Contraceptives, Oral, Combined; D011374:Progesterone; D019304:Ethinyl Estradiol-Norgestrel Combination; D004964:Estriol