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Tibolone and low-dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability.

Abstract

OBJECTIVES

The primary objective was to compare the vaginal bleeding pattern during administration of tibolone and low-dose continuous combined estradiol plus norethisterone acetate (E2/NETA). The secondary objectives were efficacy on vasomotor symptoms and vaginal atrophy.

DESIGN

A randomised, double-blind, double-dummy, group comparative intervention trial.

SETTING

Multicentre study executed in 32 centres in 7 European countries.

SAMPLE

Five hundred and seventy-two healthy symptomatic postmenopausal women, aged 45-65 years.

METHODS

Participants were randomised to receive 2.5 mg tibolone or 1 mg 17beta estradiol plus 0.5 mg norethisterone acetate (E2/NETA) daily for 48 weeks.

MAIN OUTCOME MEASURES

Prevalence of vaginal bleeding, hot flushes and adverse events.

RESULTS

The incidence of bleeding was significantly lower in the tibolone group during the first 3 months of treatment (18.3 versus 33.1%; P < 0.001) when compared with the E2/NETA group. This effect on the bleeding pattern was sustained throughout the study, although reaching statistical significance again only in 7-9 months of treatment (11 versus 19%; P < 0.05). In both treatment groups, vasomotor symptoms and vaginal atrophy were significantly reduced to a similar extent when compared with baseline. The prevalence of breast pain/tenderness was significantly lower with tibolone compared with E2/NETA (3.2 versus 9.8%; P < 0.001).

CONCLUSION

Tibolone reduces menopausal symptoms to a similar extent as conventional low-dose continuous combined hormone therapy but causes significant less vaginal bleeding in the first 3 months of treatment. This constitutes an important argument for woman adherence to therapy.

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  • Authors+Show Affiliations

    ,

    Division of Obstetrics and Gynecology, Department of Molecular and Clinical Medicine, Faculty of Health Sciences, Linköping University Hospital, Linköping, Sweden.

    , , , , ,

    Source

    MeSH

    Aged
    Contraceptives, Oral, Synthetic
    Double-Blind Method
    Drug Therapy, Combination
    Estradiol
    Estrogen Receptor Modulators
    Estrogen Replacement Therapy
    Estrogens
    Female
    Hot Flashes
    Humans
    Metrorrhagia
    Middle Aged
    Norethindrone
    Norpregnenes

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    17995496