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Tibolone and low-dose continuous combined hormone treatment: Vaginal bleeding pattern, efficacy and tolerability
Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
Van De Weijer, P., Department of Obstetrics and Gynecology, Gelre Teaching Hospital, Apeldoorn, Netherlands.
Department of Obstetrics and Gynecology, Medisch Spectrum Twente Hospital Group, Enschede, Netherlands.
Brussels Menopause Center, Brussels, Belgium.
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2007 (English)In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, Vol. 114, no 12, 1522-1529 p.Article in journal (Refereed) Published
Abstract [en]

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 17ß estradiol plus 0.5 mg norethisterone acetate (E 2/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 E 2/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. © 2007 The Authors.

Place, publisher, year, edition, pages
2007. Vol. 114, no 12, 1522-1529 p.
Keyword [en]
E2/NETA, Menopause, Tibolone, Tolerability, Vaginal bleeding
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-47610DOI: 10.1111/j.1471-0528.2007.01537.xOAI: diva2:268506
Available from: 2009-10-11 Created: 2009-10-11 Last updated: 2011-01-11

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Hammar, Mats
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Faculty of Health SciencesObstetrics and gynecology Department of Gynecology and Obstetrics in Linköping
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British Journal of Obstetrics and Gynecology
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