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Tibolone and low-do...
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Hammar, MatsÖstergötlands Läns Landsting,Linköpings universitet,Hälsouniversitetet,Obstetrik och gynekologi,Kvinnokliniken i Linköping
(författare)
Tibolone and low-dose continuous combined hormone treatment : Vaginal bleeding pattern, efficacy and tolerability
- Artikel/kapitelEngelska2007
Förlag, utgivningsår, omfång ...
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2007-11-08
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Wiley,2007
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printrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:liu-47610
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-47610URI
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https://doi.org/10.1111/j.1471-0528.2007.01537.xDOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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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.
Ämnesord och genrebeteckningar
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E2/NETA
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Menopause
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Tibolone
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Tolerability
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Vaginal bleeding
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MEDICINE
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MEDICIN
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Van, De Weijer P.Van De Weijer, P., Department of Obstetrics and Gynecology, Gelre Teaching Hospital, Apeldoorn, Netherlands
(författare)
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Franke, H.R.Department of Obstetrics and Gynecology, Medisch Spectrum Twente Hospital Group, Enschede, Netherlands
(författare)
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Pornel, B.Brussels Menopause Center, Brussels, Belgium
(författare)
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Von, Mauw E.M.J.Von Mauw, E.M.J., Global Clinical Development Department, N.V. Organon, Oss, Netherlands
(författare)
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Nijland, E.A.Department of Sexuology and Psychosomatic Obstetrics/Gynaecology, Academic Medical Center, Groningen, Netherlands, Department of Sexuology and Psychosomatic Obstetrics/Gynaecology, Academic Medical Center, Hanzeplein 1, 9713 GZ, Groningen, Netherlands
(författare)
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Linköpings universitetHälsouniversitetet
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:British Journal of Obstetrics and Gynecology: Wiley114:12, s. 1522-15291470-03281471-0528
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