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Tibolone and low-do...
Tibolone and low-dose continuous combined hormone treatment : Vaginal bleeding pattern, efficacy and tolerability
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- Hammar, Mats (författare)
- Östergötlands Läns Landsting,Linköpings universitet,Hälsouniversitetet,Obstetrik och gynekologi,Kvinnokliniken i Linköping
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- Van, De Weijer P. (författare)
- Van De Weijer, P., Department of Obstetrics and Gynecology, Gelre Teaching Hospital, Apeldoorn, Netherlands
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- Franke, H.R. (författare)
- Department of Obstetrics and Gynecology, Medisch Spectrum Twente Hospital Group, Enschede, Netherlands
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- Pornel, B. (författare)
- Brussels Menopause Center, Brussels, Belgium
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- Von, Mauw E.M.J. (författare)
- Von Mauw, E.M.J., Global Clinical Development Department, N.V. Organon, Oss, Netherlands
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- Nijland, E.A. (författare)
- 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
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(creator_code:org_t)
- 2007-11-08
- 2007
- Engelska.
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Ingår i: British Journal of Obstetrics and Gynecology. - : Wiley. - 1470-0328 .- 1471-0528. ; 114:12, s. 1522-1529
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Nyckelord
- E2/NETA
- Menopause
- Tibolone
- Tolerability
- Vaginal bleeding
- MEDICINE
- MEDICIN
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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