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P298 An open, randomized assessment of the efficacy and safety of two transdermal estradiol patches for relief of climacteric symptoms
P297 (cant)
P298
Both total hip density (0.939->0.992g/cm2) and lumbar spine[LlL4] density (0.872->0.89Og/cm2) increased as did the respective age matched scores (Z-score hip 103-O-> 111.5(8.5%) and Z-score spine 103.5->108.5(5%). The results were compared to a control group of 14 women not on reagent who were statistic~ly matched in terms of age, menopausal age and BMI. Total hip (-0.48%) and lumbar spine (-1.34%) median densities declined in the control group. Changes in bone density were significantly different (p < 0.01) in the two groups at one year. Low dose oestradiol implants and continuous norethisterone are effective in controlling bleeding without endome~~ h~e~l~ia and increase bone density in both hip and spine, This should maximise compliance in the older postmenopausal woman.
P299
AN OPEN, ~NDOMIZED ASSESSME~ OF THE EFFICACY AND SAFETY OF TWO TRANSDERMAL ESTRADIOL PATCHES FOR RELIEF OF CLIMACTERIC SYMPTOMS E Baracat, L F Aguiar, I C Barbosa, A A Campos, M Hai&r, M J WC B LeaI, G Rodrigtm de Limo, M F St& A Soares, S Wehba, N Siseles, A Porcile. Federal University of Szo Paulo. R Leandro Dupre, 325, Ssto PauloSP, 04025-01 I, Brazil. An open-label, randomized, comparative clinical trial was conducted in 10 centers in Latin America (8 in Brazil, 1 in Argentina and 1 in Chile) to assess the efficacy and safety of two ~~sde~ai estradiol systems. A total of 182 patients was randomized to have a matrix patch (Climaderm*-Wyeth-Aye&) or a reservoir patch (Estraderm* TTS 50-Ciba- Geigy) applied to alternate areas of the lower abdomen and changed twice-a-week, for 6 consecutive cycles of 28 days. Both patches were labeled to deliver 50 @day of estradiol. In both groups, there was si~i~c~t decrease from pre-~eatment in the number of hot flushes per day at cycles 1 to 6. There was a significant difference between groups at cycles 4 (p=O.O33) and 6 (p=O.O46), better for the matrix patch. There was significant difference between groups with respect to weakness at cycle 2 (p=O.O19) and 3 (p=O.OlS), tiredness at cycle 2 (p=O.O33), sleep interruptions at cycle 6 (p=O.O48), nervousness at cycle 3 (p=O.O45) and total score at cycles 2 (~.030) and 3 (~.041), better for the matrix patch. Twelve patients (12.4%)in the matrix group and 18 patients (2 1.2%) in the reservoir group withdrew from the study.
P299 (cant)
HORMONAL REPLACEMENT THERAPY (IIRT) . EVALUATION OF A NOVEL 25 DAYS REGJMEN WITH PERCUTANEOUS EST~DIOL~E2) AND MICRON~ED ORAL PROGESTERONE~P). M Maretwo, D Rodriguez Vidal E Gil Deza. PAM1 1nstitution:Sarmiento 373 (2000) Rosario. Argentina. Uterine bleeding appears to be one of the most frequent factors involved in the patient‘s decision to dis~ntinue HTR. The aim of this prospective controlled trial was to value the efficacy of a combined 25 days/calendar month of HRT (HRT-25) using PE2 in adapted dosis (1.5 or 0.75 mg/day) according to plasmatic E2 level (80-150pg/ml) and MP(lOOmg/day), given at bedtime during the same period. The efficacy was measured by Kupperman Index (KI), the capacity of amenorrhoea induction, endometrial growth control, lipid metabolism and compfiance. 112 menopause women , mean age 61 (&9.14), received the TIIR-25 and were followed during 12 months. The controls were performed at O-2-6 and 12 months of treatment. 1IO/l 12 were fully evaluable, 2 patients withdrawn: 1 due to side effects and 1 for unknown reasons. The compliance at 12 months was 98,21% KI: mean basal 48,31(2 11) mean 12 month 21,88 e 4) (p~.OOOl, t-test). A bleeding score (BS) was used to m
Continued 209
At 12 months of THR-25, ~eno~hoea was shown in 97,3% of patients and endometrial biopsies showed atrophy in 89 (810/o), subatrophy in 16(14,5%), 5 additional cases (4.5%) had inadequate tissue samples. In these cases, the mean thickness of endometrium by ultrasonography was 3 mm. Regarding the lipid tractions, the mean basal of cholesterol(Cho), HDL-C, LDL-C and TGL showed si~i~c~t changes respect to the 12 months mean (~.OOOl 2tailtest). z 12m.
Cbo(mg/dl
HDL-Cmgm
241,3 (+ 38) 209,l (+ 30,8)*
53,2 (+ 12.4) 58,2 (+ 12.5)’
LDLCmgldl 153,X+ 33) 134,3 (+ 24.3).
TGLmMl 1 151,7 (+ 47.8) 131(+ 39.5).
HRT-25 is highly effective, well tolerated and accepted (98,21% of compliance a&r 1 year).
P298
Both total hip density (0.939->0.992g/cm2) and lumbar spine[LlL4] density (0.872->0.89Og/cm2) increased as did the respective age matched scores (Z-score hip 103-O-> 111.5(8.5%) and Z-score spine 103.5->108.5(5%). The results were compared to a control group of 14 women not on reagent who were statistic~ly matched in terms of age, menopausal age and BMI. Total hip (-0.48%) and lumbar spine (-1.34%) median densities declined in the control group. Changes in bone density were significantly different (p < 0.01) in the two groups at one year. Low dose oestradiol implants and continuous norethisterone are effective in controlling bleeding without endome~~ h~e~l~ia and increase bone density in both hip and spine, This should maximise compliance in the older postmenopausal woman.
P299
AN OPEN, ~NDOMIZED ASSESSME~ OF THE EFFICACY AND SAFETY OF TWO TRANSDERMAL ESTRADIOL PATCHES FOR RELIEF OF CLIMACTERIC SYMPTOMS E Baracat, L F Aguiar, I C Barbosa, A A Campos, M Hai&r, M J WC B LeaI, G Rodrigtm de Limo, M F St& A Soares, S Wehba, N Siseles, A Porcile. Federal University of Szo Paulo. R Leandro Dupre, 325, Ssto PauloSP, 04025-01 I, Brazil. An open-label, randomized, comparative clinical trial was conducted in 10 centers in Latin America (8 in Brazil, 1 in Argentina and 1 in Chile) to assess the efficacy and safety of two ~~sde~ai estradiol systems. A total of 182 patients was randomized to have a matrix patch (Climaderm*-Wyeth-Aye&) or a reservoir patch (Estraderm* TTS 50-Ciba- Geigy) applied to alternate areas of the lower abdomen and changed twice-a-week, for 6 consecutive cycles of 28 days. Both patches were labeled to deliver 50 @day of estradiol. In both groups, there was si~i~c~t decrease from pre-~eatment in the number of hot flushes per day at cycles 1 to 6. There was a significant difference between groups at cycles 4 (p=O.O33) and 6 (p=O.O46), better for the matrix patch. There was significant difference between groups with respect to weakness at cycle 2 (p=O.O19) and 3 (p=O.OlS), tiredness at cycle 2 (p=O.O33), sleep interruptions at cycle 6 (p=O.O48), nervousness at cycle 3 (p=O.O45) and total score at cycles 2 (~.030) and 3 (~.041), better for the matrix patch. Twelve patients (12.4%)in the matrix group and 18 patients (2 1.2%) in the reservoir group withdrew from the study.
P299 (cant)
HORMONAL REPLACEMENT THERAPY (IIRT) . EVALUATION OF A NOVEL 25 DAYS REGJMEN WITH PERCUTANEOUS EST~DIOL~E2) AND MICRON~ED ORAL PROGESTERONE~P). M Maretwo, D Rodriguez Vidal E Gil Deza. PAM1 1nstitution:Sarmiento 373 (2000) Rosario. Argentina. Uterine bleeding appears to be one of the most frequent factors involved in the patient‘s decision to dis~ntinue HTR. The aim of this prospective controlled trial was to value the efficacy of a combined 25 days/calendar month of HRT (HRT-25) using PE2 in adapted dosis (1.5 or 0.75 mg/day) according to plasmatic E2 level (80-150pg/ml) and MP(lOOmg/day), given at bedtime during the same period. The efficacy was measured by Kupperman Index (KI), the capacity of amenorrhoea induction, endometrial growth control, lipid metabolism and compfiance. 112 menopause women , mean age 61 (&9.14), received the TIIR-25 and were followed during 12 months. The controls were performed at O-2-6 and 12 months of treatment. 1IO/l 12 were fully evaluable, 2 patients withdrawn: 1 due to side effects and 1 for unknown reasons. The compliance at 12 months was 98,21% KI: mean basal 48,31(2 11) mean 12 month 21,88 e 4) (p~.OOOl, t-test). A bleeding score (BS) was used to m
Continued 209
At 12 months of THR-25, ~eno~hoea was shown in 97,3% of patients and endometrial biopsies showed atrophy in 89 (810/o), subatrophy in 16(14,5%), 5 additional cases (4.5%) had inadequate tissue samples. In these cases, the mean thickness of endometrium by ultrasonography was 3 mm. Regarding the lipid tractions, the mean basal of cholesterol(Cho), HDL-C, LDL-C and TGL showed si~i~c~t changes respect to the 12 months mean (~.OOOl 2tailtest). z 12m.
Cbo(mg/dl
HDL-Cmgm
241,3 (+ 38) 209,l (+ 30,8)*
53,2 (+ 12.4) 58,2 (+ 12.5)’
LDLCmgldl 153,X+ 33) 134,3 (+ 24.3).
TGLmMl 1 151,7 (+ 47.8) 131(+ 39.5).
HRT-25 is highly effective, well tolerated and accepted (98,21% of compliance a&r 1 year).