Tibolone and low-dose continuous combined hormone treatment: Vaginal bleeding pattern, efficacy and tolerability
2007 (English)In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, Vol. 114, no 12, 1522-1529 p.Article in journal (Refereed) Published
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.
E2/NETA, Menopause, Tibolone, Tolerability, Vaginal bleeding
National CategoryMedical and Health Sciences
IdentifiersURN: urn:nbn:se:liu:diva-47610DOI: 10.1111/j.1471-0528.2007.01537.xOAI: oai:DiVA.org:liu-47610DiVA: diva2:268506