OBJECTIVE: To investigate endometrial effects of tibolone administered to postmenopausal women for 3 years. METHODS:Postmenopausal women (N=3,519) aged 60-85 years (mean 68 years) with a uterus and with osteoporosis were randomly assigned to receive tibolone orally, 1.25 mg per day, or identical placebo. We evaluated effects on endometrial thickness in all women, and examined endometrial histology in 635 participants considered to be at increased risk for abnormalities (with unexpected vaginal bleeding or endometrial thickness more than 4 mm). RESULTS: During the first year of study, mean endometrial thickness increased 1 mm in women receiving tibolone (P<.001), but no further increases were noted during the next 2 years. Diagnostic biopsies among 499 women receivingtibolone and 136 who were receiving placebo showed cumulative incidences of endometrial hyperplasia less than 1%. Among the 15% of women whose biopsy showed an endometrial polyp (similar rate in tibolone and placebo), those receiving tibolone were more than twice as likely to show hyperplasia within the polyp. A marginal increase in grade 1 endometrioid adenocarcinoma (P=.06 compared with placebo) was found among women receiving tibolone. Prevalences of vaginal bleeding during the study were 10.8% in the tibolone group and 2.8% in the placebo group (P<.001). CONCLUSION:Tibolone treatment during 3 years minimally increased endometrial thickness, hyperplastic polyps, endometrial carcinoma, and vaginal bleeding.
RCT Entities:
OBJECTIVE: To investigate endometrial effects of tibolone administered to postmenopausal women for 3 years. METHODS: Postmenopausal women (N=3,519) aged 60-85 years (mean 68 years) with a uterus and with osteoporosis were randomly assigned to receive tibolone orally, 1.25 mg per day, or identical placebo. We evaluated effects on endometrial thickness in all women, and examined endometrial histology in 635 participants considered to be at increased risk for abnormalities (with unexpected vaginal bleeding or endometrial thickness more than 4 mm). RESULTS: During the first year of study, mean endometrial thickness increased 1 mm in women receiving tibolone (P<.001), but no further increases were noted during the next 2 years. Diagnostic biopsies among 499 women receiving tibolone and 136 who were receiving placebo showed cumulative incidences of endometrial hyperplasia less than 1%. Among the 15% of women whose biopsy showed an endometrial polyp (similar rate in tibolone and placebo), those receiving tibolone were more than twice as likely to show hyperplasia within the polyp. A marginal increase in grade 1 endometrioid adenocarcinoma (P=.06 compared with placebo) was found among women receiving tibolone. Prevalences of vaginal bleeding during the study were 10.8% in the tibolone group and 2.8% in the placebo group (P<.001). CONCLUSION:Tibolone treatment during 3 years minimally increased endometrial thickness, hyperplastic polyps, endometrial carcinoma, and vaginal bleeding.
Authors: Steven R Cummings; Bruce Ettinger; Pierre D Delmas; Peter Kenemans; Victoria Stathopoulos; Pierre Verweij; Mirjam Mol-Arts; Lenus Kloosterboer; Lori Mosca; Claus Christiansen; John Bilezikian; Eduardo Mario Kerzberg; Susan Johnson; Jose Zanchetta; Diederich E Grobbee; Wilfried Seifert; Richard Eastell Journal: N Engl J Med Date: 2008-08-14 Impact factor: 91.245
Authors: Günter Emons; Eric Steiner; Dirk Vordermark; Christoph Uleer; Nina Bock; Kerstin Paradies; Olaf Ortmann; Stefan Aretz; Peter Mallmann; Christian Kurzeder; Volker Hagen; Birgitt van Oorschot; Stefan Höcht; Petra Feyer; Gerlinde Egerer; Michael Friedrich; Wolfgang Cremer; Franz-Josef Prott; Lars-Christian Horn; Heinrich Prömpeler; Jan Langrehr; Steffen Leinung; Matthias W Beckmann; Rainer Kimmig; Anne Letsch; Michael Reinhardt; Bernd Alt-Epping; Ludwig Kiesel; Jan Menke; Marion Gebhardt; Verena Steinke-Lange; Nils Rahner; Werner Lichtenegger; Alain Zeimet; Volker Hanf; Joachim Weis; Michael Mueller; Ulla Henscher; Rita K Schmutzler; Alfons Meindl; Felix Hilpert; Joan Elisabeth Panke; Vratislav Strnad; Christiane Niehues; Timm Dauelsberg; Peter Niehoff; Doris Mayr; Dieter Grab; Michael Kreißl; Ralf Witteler; Annemarie Schorsch; Alexander Mustea; Edgar Petru; Jutta Hübner; Anne Derke Rose; Edward Wight; Reina Tholen; Gerd J Bauerschmitz; Markus Fleisch; Ingolf Juhasz-Boess; Lax Sigurd; Ingo Runnebaum; Clemens Tempfer; Monika J Nothacker; Susanne Blödt; Markus Follmann; Thomas Langer; Heike Raatz; Simone Wesselmann; Saskia Erdogan Journal: Geburtshilfe Frauenheilkd Date: 2018-10-19 Impact factor: 2.915