Prospective, randomised study with three HRT regimens in postmenopausal women with an intact uterus.
OBJECTIVE
To compare compliance, symptom control, bleeding patterns, lipid and biochemical changes in postmenopausal women treated with three regimens of HRT.


METHODS
In a prospective, randomised, group comparative study, with 165 patients, the effects on the aforementioned parameters, as well as treatment compliance and side effects were studied with oral tibolone 2.5 mg per day, with cyclic combined regimen of transdermal oestrogen and progestogen (transdermal patch of 17beta-oestradiol 50 microg/day during 14 days and transdermal patch of 17beta-oestradiol 50 microg/day plus 0.25 mg/day NETA during the following 14 days), and with intermittent progesterone regimen (transdermal 17beta-oestradiol 50 microg/day and oral micronised natural progesterone 200 mg twice a week). Statistical analysis was carried out using the Fisher-test, analysis of the variance (ANOVA) and the Bouferoni test.


RESULTS
Ten women dropped out of the tibolone group, 11 dropped out of the intermittent dosing group and 21 dropped out of the cyclid combined group. Irregular bleeding occurred at more rates in the cyclid combined group. Similar reductions in climacteric symptoms were found in the three groups. No differences were observed with respect to biochemical analysis.


CONCLUSIONS
Efficacy and safety of the three treatment regimens being comparable, but the patients in our study preferred those that did not produce bleeding episodes.
Mendoza
N
N
Department of Obstetrics and Gynecology, Hospital Virgen de las Nievas, Avda. Fuerzas Armadas s/n, 18014 Granada, Spain. mmendozal@sego.es
Pisón
J A
JA
Fernández
M
M
Sánchez
M C
MC
Malde
J
J
Miranda
J A
JA
D000279:Administration, Cutaneous; D004958:Estradiol / Q000009:adverse effects / Q000627:therapeutic use; D020847:Estrogen Receptor Modulators / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D008875:Middle Aged; D009652:Norpregnenes / Q000009:adverse effects / Q000627:therapeutic use; D010349:Patient Compliance; D017698:Postmenopause; D011374:Progesterone / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D012449:Safety; D014599:Uterus
D020847:Estrogen Receptor Modulators; D009652:Norpregnenes; D011374:Progesterone; D004958:Estradiol; C027385:tibolone