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Tibolone and low-dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability.
OBJECTIVESThe 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.
DESIGNA randomised, double-blind, double-dummy, group comparative intervention trial.
SETTINGMulticentre study executed in 32 centres in 7 European countries.
SAMPLEFive hundred and seventy-two healthy symptomatic postmenopausal women, aged 45-65 years.
METHODSParticipants were randomised to receive 2.5 mg tibolone or 1 mg 17beta estradiol plus 0.5 mg norethisterone acetate (E2/NETA) daily for 48 weeks.
MAIN OUTCOME MEASURESPrevalence of vaginal bleeding, hot flushes and adverse events.
RESULTSThe 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 E2/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).
CONCLUSIONTibolone 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.
Division of Obstetrics and Gynecology, Department of Molecular and Clinical Medicine, Faculty of Health Sciences, Linköping University Hospital, Linköping, Sweden., , , , ,
BJOG : an international journal of obstetrics and gynaecology 114:12 2007 Dec pg 1522-9
Contraceptives, Oral, Synthetic
Drug Therapy, Combination
Estrogen Receptor Modulators
Estrogen Replacement Therapy
Pub Type(s)Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't