Print Email Facebook Twitter The effects of 12 weeks of HMR 3339, a novel selective estrogen receptor modulator, on markers of coagulation and fibrinolysis: A randomized, placebo-controlled, double-blind, dose-ranging study in healthy postmenopausal women Title The effects of 12 weeks of HMR 3339, a novel selective estrogen receptor modulator, on markers of coagulation and fibrinolysis: A randomized, placebo-controlled, double-blind, dose-ranging study in healthy postmenopausal women Author Vogelvang, T.E. Mijatovic, V. Kenemans, P. Emeis, J.J. Heijst, J.A. van der Mooren, M.J. TNO Preventie en Gezondheid Publication year 2005 Abstract Objective: To investigate the short-term effects of HMR 3339, a novel selective estrogen receptor modulator, on markers of coagulation and fibrinolysis. Study design: In a multicenter, 14-week, randomized, placebo-controlled, double-blind, dose-ranging study, healthy postmenopausal women received daily placebo (n = 22), HMR 3339 2.5 mg (n = 25), HMR 3339 10 mg (n = 24), HMR 3339 50 mg (n = 24), or raloxifene 60 mg (n = 23). Statistical analysis was performed using standard parametric tests. Results: After 12 weeks, compared with placebo, HMR 3339 50 mg induced the largest mean percentage changes in antithrombin (-14.6%, P < .001), protein C (-12.9%, P = .029), and fibrinogen (-26.3%, P = .001). Decreases were observed in the HMR 3339 2.5 mg group, compared with placebo, in tissue-type plasminogen activator (-55.0%, P = .026 after 4 weeks), plasmin-α2-antiplasmin complex (-85%, P = .031 and -63.3%, P = .008, respectively, after 4 and 12 weeks), and D-dimer (-91.4%, P = .018 after 12 weeks). Compared with placebo, raloxifene 60 mg decreased total protein S (-8.2%, P = .009) after 4 weeks and antithrombin (-6.0%, P = .034) and fibrinogen (-18.1%, P = .007) after 12 weeks. Conclusion: HMR 3339 and raloxifene decreased fibrinogen levels. In the low dosage, HMR 3339 showed potentially beneficial effects on some markers of fibrinolysis. Both drugs impaired the anticoagulatory potential. © 2005 Mosby, Inc. All rights resrved. Chemicals / CAS: antithrombin, 9000-94-6; fibrinogen, 9001-32-5; protein C, 60202-16-6; raloxifene, 82640-04-8, 84449-90-1; tissue plasminogen activator, 105913-11-9; Biological Markers; Estradiol, 50-28-2; HMR 3339; Raloxifene, 84449-90-1; Selective Estrogen Receptor Modulators Subject CoagulationFibrinolysisHMR 3339MenopauseRaloxifeneantithrombinD dimerhmr 339protein Cprotein Sraloxifeneselective estrogen receptor modulatortissue plasminogen activatoradultagedblood clottingclinical trialcontrolled clinical trialcontrolled studydouble blind proceduredrug effectmulticenter studyparameterpostmenopauseprotein blood levelrandomized controlled trialstatistical analysisBiological MarkersBlood CoagulationDose-Response Relationship, DrugDouble-Blind MethodEstradiolFemaleHumansMiddle AgedPostmenopauseRaloxifeneSelective Estrogen Receptor ModulatorsTime Factors To reference this document use: http://resolver.tudelft.nl/uuid:65c5dd11-1bb0-4672-a42c-7dd4632c6d57 DOI https://doi.org/10.1016/j.ajog.2005.02.083 TNO identifier 238731 ISSN 0002-9378 Source American Journal of Obstetrics and Gynecology, 193 (4), 1384-1394 Document type article Files To receive the publication files, please send an e-mail request to TNO Library.