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

Abstract

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.

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  • Authors+Show Affiliations

    ,

    Santa Cristina University Hospital, Universidad Autónoma de Madrid, Madrid, Spain. tperezm@meditex.es

    , , , , ,

    Source

    MeSH

    Adult
    Endometrial Hyperplasia
    Estrogen Receptor Modulators
    Estrogen Replacement Therapy
    Female
    Humans
    Middle Aged
    Norpregnenes
    Polyps
    Postmenopause
    Prospective Studies
    Risk Factors

    Pub Type(s)

    Comparative Study
    Journal Article

    Language

    eng

    PubMed ID

    14627862