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Tibolone and risk of endometrial polyps: a prospective, comparative study with hormone therapy

Perez-Medina, Tirso MD, PhD1; Bajo-Arenas, José MD, PhD1; Haya, Javier MD, PhD1; Sanfrutos, Luis MD, PhD1; Iniesta, Silvia MD1; Bueno, Beatriz MD1; Castelo-Branco, Camil MD, PhD2

doi: 10.1097/01.GME.0000064815.74043.32

Objective To assess the incidence of endometrial polyps during postmenopausal replacement therapy with tibolone, using an appropriate control group.

Design A total of 485 postmenopausal women were included in this open, prospective, comparative study for a duration of 36 months. Of this group, 249 women received 2.5 mg/day of tibolone and 244 women served as controls, receiving continuous-combined estrogen-progestogen therapy (HT). Transvaginal ultrasound, hysteroscopy, and directed biopsies were performed before treatment was initiated and at the end of the study.

Results Two hundred twenty-one of the women receiving tibolone and 203 receiving continuous-combined HT completed the study. Endometrial polyps were detected in 74 women (33.4%) from the tibolone group and in 22 women (10.8%) from the HT group (P < 0.01). The vaginal bleeding rate did not differ between the groups. The frequency of atrophic polyps was significantly higher in the tibolone group (P < 0.01). No difference was found in the size of the polyps.

Conclusions Tibolone increases by threefold the risk for endometrial polyps.

From 1Santa Cristina University Hospital, Universidad Autónoma de Madrid, Madrid, Spain; and 2Hospital Clinic, University of Barcelona, Barcelona, Spain.

Received November 29, 2002; revised and accepted February 13, 2003.

Address correspondence to: Tirso Perez-Medina, MD, Santa Cristina University Hospital, Universidad Autónoma de Madrid, C/ O'Donnell, 59, 28009 Madrid, Spain. E-mail:

©2003The North American Menopause Society