TY - JOUR T1 - Improved bleeding profile and tolerability of tibolone versus transdermal E2/NETA treatment in postmenopausal women with female sexual dysfunction. AU - Nijland,E A, AU - Nathorst-Böös,J, AU - Palacios,S, AU - van de Weijer,P W, AU - Davis,S, AU - Stathopoulos,V M, AU - Birkhaeuser,M H, AU - von Mauw,E, AU - Mulder,R J, AU - Schultz,W C M Weijmar, AU - ,, PY - 2009/1/30/entrez PY - 2009/1/30/pubmed PY - 2009/6/6/medline SP - 114 EP - 21 JF - Climacteric : the journal of the International Menopause Society JO - Climacteric VL - 12 IS - 2 N2 - OBJECTIVES: To compare the incidence of vaginal spotting/bleeding events and breast pain between therapy with tibolone 2.5 mg and continuous combined transdermal estradiol (E(2))/norethisterone acetate (NETA) 50 microg/140 microg after 24 weeks of treatment. METHODS: A double-blind, double-dummy, randomized, controlled trial was performed and assessments were performed at baseline, week 12 and week 24. Bleeding/spotting events were recorded in a daily diary. Breast signs and symptoms were collected as adverse events. RESULTS: A total of 403 women (mean age 56 years) were randomized. Bleeding/spotting events during weeks 1-12 with tibolone and E(2)/NETA were experienced by 16% and 56% of women, respectively (p < 0.001). The corresponding percentages during weeks 13-24 were 12% and 51%, respectively (p < 0.001). E(2)/NETA was significantly more likely than tibolone to be associated with vaginal hemorrhage (11% vs. 0%; p < 0.001) and breast signs and symptoms (11% vs. 4%; p = 0.015). Early discontinuations resulting from adverse events were significantly more common in the E(2)/NETA group than in the tibolone group (20% vs. 12%), primarily related to withdrawal due to vaginal hemorrhage (8% vs. 0%). CONCLUSIONS: Tibolone has a significantly better tolerability profile than transdermal E(2)/NETA as measured by vaginal bleeding, breast pain and treatment continuation. SN - 1473-0804 UR - https://www.unboundmedicine.com/medline/citation/19177255/Improved_bleeding_profile_and_tolerability_of_tibolone_versus_transdermal_E2/NETA_treatment_in_postmenopausal_women_with_female_sexual_dysfunction_ L2 - https://www.tandfonline.com/doi/full/10.1080/13697130802576666 DB - PRIME DP - Unbound Medicine ER -