natgillin/translations-raw huggingface dataset:
Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in OPTRUMA patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3% OPTRUMA and 18.2% placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6% for OPTRUMA and 7.1% placebo).
În compara ie cu pacientele c rora li s- a administrat placebo, apari ia vasodilata iei (bufeurilor) a fost modest crescut la pacientele tratate cu OPTRUMA (studiile clinice pentru prevenirea osteoporozei, 2 pân la 8 ani postmenopauz, 24, 3% OPTRUMA i 18, 2% placebo; studiile clinice pentru tratamentul osteoporozei, vârsta medie 66 ani, 10, 6% pentru OPTRUMA i 7, 1% placebo).
This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time.
Aceast reac ie advers a ap rut cel mai frecvent în primele 6 luni de tratament i rar de novo dup acest interval.
In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8% in the raloxifene-treated patients and 4.7% in the placebo-treated patients.
Într- un studiu ce a inclus 10101 femei în postmenopauz cu boal coronarian documentat sau cu risc crescut de evenimente coronariene (RUTH), inciden a vasodilata iei (bufeuri) a fost de 7, 8% în grupul de paciente tratate cu raloxifen i de 4, 7% în grupul placebo.
Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8% or 3.22 cases per 1,000 patient years.
În cadrul tuturor studiilor clinice cu raloxifen în tratamentul osteoporozei, controlate placebo, evenimentele tromboembolice venoase, incluzând tromboza venoas profund, embolia pulmonar i tromboza venoas retinian, au ap rut cu o frecven de aproximativ 0, 8% sau 3, 22 cazuri pe 1000 ani pacient.
A relative risk of 1.60 (CI 0.95, 2.71) was observed in OPTRUMA treated patients compared to placebo.
La pacientele tratate cu OPTRUMA s- a observat un risc relativ de 1, 60 (CI 0, 95; 2, 71), în compara ie cu placebo.
Superficial vein thrombophlebitis occurred in a frequency of less than 1%.
Tromboflebita venoas superficial a ap rut cu o frecven mai mic de 1%.
In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0% or 3.88 cases per 1000 patient-years in the raloxifene group and 1.4% or 2.70 cases per 1000 patient-years in the placebo group.
În studiul RUTH, evenimentele tromboembolice venoase au ap rut cu o frecven de aproximativ 2, 0% sau 3, 88 cazuri la 1000 pacen i- ani în grupul tratat cu raloxifen i de 1, 4% sau 2, 70 cazuri la 1000 pacien i- ani în grupul placebo.
The hazard ratio for all VTE events in the RUTH study was
Raportul de risc pentru toate evenimentele TEV în studiul RUTH
5 HR = 1.44, (1.06 – 1.95).
5 a fost RR = 1, 44 (1, 06 - 1, 95).
Superficial vein thrombophlebitis occurred in a frequency of 1% in the raloxifene group and 0.6% in the placebo group.
Tromboflebita venoas superficial a ap rut cu o frecven de 1% în grupul tratat cu raloxifen i 0, 6% în grupul placebo.
Another adverse reaction observed was leg cramps (5.5% for OPTRUMA, 1.9% for placebo in the prevention population and 9.2% for OPTRUMA, 6.0% for placebo in the treatment population).
O alt reac ie advers observat a fost apari ia crampelor membrelor inferioare (5, 5% pentru OPTRUMA, 1, 9% pentru placebo în popula ia studiilor de prevenire i 9, 2% pentru OPTRUMA, 6, 0% pentru placebo în popula ia studiilor de tratament al ostoporozei).
In the RUTH study, leg cramps were observed in 12.1% of raloxifene-treated patients and 8.3% of placebo-treated patients.
În studiul RUTH, crampele membrelor inferioare au fost observate la 12, 1% dintre pacientele tratate cu raloxifen i la 8, 3% dintre pacientele c rora li s- a administrat placebo.
Flu syndrome was reported by 16.2% of OPTRUMA treated patients and 14.0% of placebo treated patients.
Sindromul gripal a fost raportat de 16, 2% dintre pacientele tratate cu OPTRUMA i de 14, 0% dintre pacientele c rora li s- a administrat placebo.
One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend.
A fost constatat i o alt modificare, care nu a fost semnificativ statistic (p > 0, 05), dar care a manifestat o semnificativ tendin de dependen de doz.
This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1% for OPTRUMA and 1.9% for placebo; and in the treatment population occurred at an incidence of 7.1% for OPTRUMA and 6.1% for placebo.
Ea a fost reprezentat de edemele periferice, care au ap rut la popula ia studiilor de prevenire cu frecven a de 3, 1% pentru OPTRUMA i de 1, 9% pentru placebo, iar în popula ia studiilor de tratament cu frecven a de 7, 1% pentru OPTRUMA i de 6, 1% pentru placebo.
In the RUTH study, peripheral oedema occurred in 14.1% of the raloxifene-treated patients and 11.7% of the placebo-treated patients, which was statistically significant.
În studiul RUTH, edemele periferice au ap rut la 14, 1% dintre pacientele tratate cu raloxifen i 11, 7% dintre pacientele c rora li s- a administrat placebo, ceea ce a fost semnificativ statistic.
Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo- controlled clinical trials of raloxifene in osteoporosis.
În studiile clinice controlate cu placebo privind tratamentul cu raloxifen al osteoporozei, în cursul tratamentului cu raloxifen s- a raportat sc derea u oar (6- 10%) a num rului de trombocite.
Rare cases of moderate increases in AST and/ or ALT have been reported where a causal relationship to raloxifene can not be excluded.
Au fost raportate cazuri rare de cre teri moderate ale ASAT i/ sau ALAT, în care nu s- a putut exclude o rela ie cauzal cu raloxifenul.
A similar frequency of increases was noted among placebo patients.
La pacientele cu placebo a fost consemnat o frecven similar a acestor cre teri.
In a study (RUTH) of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an additional adverse reaction of cholelithiasis occurred in 3.3% of patients treated with raloxifene and 2.6% of patients treated with placebo.
Într- un studiu (RUTH) la femei în postmenopauz cu boal coronarian documentat sau cu risc crescut de evenimente coronariene, a ap rut suplimentar o reac ie advers de litiaz biliar la 3, 3% dintre pacientele tratate cu raloxifen i la 2, 6% dintre pacientele c rora li s- a administrat placebo.
Cholecystectomy rates for raloxifene (2.3%) were not statistically significantly different from placebo (2.0%).
Frecven a colecistectomiilor în grupul tratat cu raloxifen (2, 3%) nu a fost semnificativ statistic diferit de cea a grupului placebo (2, 0%).
OPTRUMA (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
OPTRUMA (n = 317) a fost comparat cu tratamentul hormonal de substitu ie (THS) continuu combinat (n = 110) sau ciclic (n = 205) în câteva studii clinice.
The incidence of breast symptoms and uterine bleeding in raloxifene treated women was significantly lower than in women treated with either form of HRT.
Inciden a simptomelor mamare i a hemoragiilor uterine la femeile tratate cu raloxifen a fost semnificativ mai mic decât la femeile tratate cu oricare din formele de THS.
The adverse reactions reported in post-marketing experience are presented in the table below.
Reac iile adverse care au fost raportate dup punerea pe pia sunt prezentate în tabelul urm tor.
Blood and lymphatic system disorders Very rare: thrombocytopenia Gastrointestinal disorders Very rare:
Tulbur ri hematologice i limfatice Foarte rare: trombocitopenie Tulbur ri gastro- intestinale Foarte rare:
Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, dyspepsia General disorders and administration site conditions Rare: peripheral oedema Investigations Very rare:
Simptome gastro- intestinale cum sunt grea, v rs turi, durere abdominal i dispepsie Tulbur ri generale i la nivelul locului de administrare Rare: edeme periferice Investiga ii diagnostice Foarte rare:
Increased blood pressure Nervous system disorders Very rare:
Tensiune arterial crescut Tulbur ri ale sistemului nervos Foarte rare:
Headache, including migraine Skin and subcutaneous tissue disorders Very rare:
Cefalee, inclusiv migren Afec iuni cutanate i ale esutului subcutanat Foarte rare:
Rash Reproductive system and breast disorders Very rare:
Erup ii cutanate Tulbur ri ale aparatului genital i sânului Foarte rare:
Mild breast symptoms such as pain, enlargement and tenderness.
Simptome mamare u oare cum sunt durere, cre tere în dimensiuni i sensibilitate.
Vascular disorders Rare: venous thromboembolic reaction Very rare: arterial thromboembolic reaction
Tulbur ri vasculare Rare: reac ie tromboembolic venoas Foarte rare: reac ie tromboembolic arterial 6 4. 9 Supradozaj
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
În unele studii clinice, au fost administrate doze zilnice de pân la 600 mg timp de 8 s pt mâni i de 120 mg timp de 3 ani.
In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
La adul i, simptome de tip crampe ale membrelor inferioare sau ame eala au fost raportate la pacien i care au luat mai mult de 120 mg într- o singur administrare.
In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg.
În supradoz ri accidentale la copii cu vârsta mai mic de 2 ani, doza maxim raportat a fost de 180 mg.
In children, symptoms of accidental overdoseincluded ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
La copii, simptomele supradozajului accidental au inclus ataxie, ame eal, v rs turi, erup ii cutanate, diaree, tremor, bufeuri i cre teri ale fosfatazei alcaline.
The highest overdose has been approximately 1.5 grams.
Cea mai mare supradoz a fost de aproximativ 1, 5 grame.
There is no specific antidote for raloxifene hydrochloride.
Nu exist un antidot specific al clorhidratului de raloxifen.
Pharmaco-therapeutic group:
Grupa farmacoterapeutic:
Selective Oestrogen Receptor Modulator.
Modulator Selectiv al Receptorilor Estrogenici (MSRE).
As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
Ca modulator selectiv al receptorului de estrogen (MSRE), raloxifenul are activit i selective agoniste sau antagoniste asupra esuturilor responsive la estrogeni.
It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
El ac ioneaz ca agonist asupra esutului osos i par ial asupra metabolismului colesterolului (sc derea colesterolului total i LDL), dar nu i în hipotalamus sau în esuturile uterine sau mamare.
Raloxifene 'biological actions, like those of oestrogen, are mediated through high affinity binding to s oestrogen receptors and regulation of gene expression.
Ca i ac iunile estrogenilor, ac iunile biologice ale raloxifenului sunt mediate de legarea cu înalt afinitate de receptorii estrogenici i de reglarea expresiei genice.
This binding results in differential expression of multiple oestrogen-regulated genes in different tissues.
Aceast legare determin expresia diferen iat a unor multiple gene reglate de estrogeni, în diferite esuturi.
Recent data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/ or gene-specific.
Datele recente sugereaz c receptorul estrogenic poate s regleze expresia genelor pe cel pu in dou c i distincte, care au specificitate de ligand, esut i/ sau gen.
The decrease in oestrogen availability which occurs at menopause, leads to marked increases in bone resorption, bone loss and risk of fracture.
Sc derea disponibilit ii estrogenilor care apare la menopauz duce la cre teri marcate ale resorb iei osoase, pierderi osoase i risc de fracturi.
Bone loss is particularly rapid for the first 10 years after menopause when the compensatory increase in bone formation is inadequate to keep up with resorptive losses.
Pierderea de substan osoas este deosebit de rapid în primii 10 ani dup menopauz, când cre terea compensatorie a form rii de os este inadecvat i nu poate compensa pierderile resorbtive.
Other risk factors which may lead to the development of osteoporosis include early menopause; osteopenia (at least 1 SD below peak bone mass); thin body build; Caucasian or Asian ethnic origin; and a family history of osteoporosis.
Al i factori de risc care pot s duc la apari ia osteoporozei includ menopauza precoce; osteopenia (cel pu in 1 DS sub masa osoas maxim); constitu ia somatic gracil; originea etnic caucazian sau asiatic; istoricul familial de osteoporoz.
Replacement therapies generally reverse the excessive resorption of bone.
Terapiile de substitu ie inhib în general resorb ia osoas excesiv.
In postmenopausal women with osteoporosis, OPTRUMA reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
La femeile în postmenopauz care au osteoporoz, OPTRUMA reduce inciden a fracturilor vertebrale, p streaz masa osoas i cre te densitatea mineral osoas (DMO).
Based on these risk factors, prevention of osteoporosis with OPTRUMA is indicated for women within ten years of menopause, with BMD of the spine between 1.0 and 2.5 SD below the mean value of a normal young population, taking into account their high lifetime risk for osteoporotic fractures.
Pe baza acestor factori de risc, prevenirea osteoporozei cu OPTRUMA este indicat la femeile care se afl în primii zece ani de la instalarea menopauzei, cu DMO al coloanei vertebrale între 1, 0 i 2, 5 DS sub valoarea medie a popula iei tinere normale, inând seama de riscul lor ridicat de fracturi osteoporotice pe parcursul vie ii.
Likewise, OPTRUMA is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/ or with vertebral fractures, irrespective of BMD.
De asemenea, OPTRUMA este indicat în tratamentul osteoporozei sau osteoporozei diagnosticate la femeile cu DMO al coloanei vertebrale cu 2, 5 DS sub valoarea medie a popula iei tinere normale i/ sau cu fracturi vertebrale, indiferent de DMO.
i) Incidence of fractures.
7 i) Inciden a fracturilor.
Forty five women with osteoporosis or 15 women with
Într- un studiu la 7705 femei în postmenopauz, cu vârsta medie de 66 de ani i cu osteoporoz sau osteoporoz cu o fractur existent, tratamentul cu OPTRUMA timp de 3 ani a redus inciden a fracturilor vertebrale cu 47% (RR 0, 53, IÎ 0, 35, 0, 79; p < 0, 001) i, respectiv, cu 31% (RR 0, 69, IÎ 0, 56, 0, 86; p < 0, 001).
7 osteoporosis with an existing fracture would need to be treated with OPTRUMA for 3 years to prevent one or more vertebral fractures.
Pentru a preveni una sau mai multe fracturi vertebrale, 45 de femei cu osteoporoz sau 15 femei cu osteoporoz i o fractur existent ar fi necesar s fie tratate cu OPTRUMA timp de 3 ani.
OPTRUMA treatment for 4 years reduced the incidence of vertebral fractures by 46% (RR 0.54, CI 0.38, 0.75) and 32% (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
Tratamentul cu OPTRUMA timp de 4 ani a redus frecven a fracturilor vertebrale cu 46% (RR 0, 54, IÎ 0, 38, 0, 75) i, respectiv, cu 32% (RR 0, 68, IÎ 0, 56, 0, 83) la pacientele cu osteoporoz sau cu osteoporoz cu o fractur vertebral existent.
In the 4th year alone, OPTRUMA reduced the new vertebral fracture risk by 39% (RR 0.61, CI 0.43, 0.88).
Exclusiv în cel de- al patrulea an, OPTRUMA a redus riscul de o nou fractur vertebral cu 39% (RR 0, 61, IÎ 0, 43, 0, 88).
From the 4th to the 8th year, patients were permitted the concomitant use of bisphosphonates, calcitonin and fluorides and all patients in this study received calcium and vitamin D supplementation.
Din al 4- lea pân în cel de- al 8- lea an, pacientelor li s- a permis utilizarea concomitent de bifosfona i, calcitonin i fluoruri i toate pacientele din acest studiu au primit suplimente de calciu i vitamin D.
In the RUTH study overall clinical fractures were collected as a secondary endpoint.
În studiul RUTH, drept criteriu secundar final de evaluare, s- a sumat num rul total de fracturi clinice.
Optruma reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47 0.89).
OPTRUMA a redus inciden a fracturilor clinice la nivel vertebral cu 35% fa de placebo (RR 0, 65, IÎ 0, 47 0, 89).
These results may have been confounded by baseline differences in BMD and vertebral fractures.
Este posibil ca aceste rezultate s fi fost influen ate de diferen ele ini iale ale DMO i de fracturile vertebrale.
During the whole length of the study concomitant use of other bone-active medications was permitted.
Pe întreaga durat a studiului a fost permis utilizarea concomitent a altor medica ii cu ac iune la nivelul osului.
ii) Bone Mineral Density (BMD):
ii) Densitatea Mineral Osoas (DMO):
The efficacy of OPTRUMA once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
Eficacitatea OPTRUMA administrat o dat pe zi la femeile în postmenopauz, în vârst de pân la 60 de ani, cu sau f r uter, a fost stabilit pe parcursul unei perioade de tratament de doi ani.
The women were 2 to 8 years postmenopausal.
Femeile erau în postmenopauz de 2 pân la 8 ani.
Three trials included 1,764 postmenopausal women who were treated with OPTRUMA and calcium or calcium supplemented placebo.
Trei studii au inclus 1764 femei în postmenopauz care au fost tratate cu OPTRUMA i calciu sau cu placebo suplimentat cu calciu.
In one of these trials the women had previously undergone hysterectomy.
Într- unul din aceste studii femeile suferiser anterior o histerectomie.
OPTRUMA produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
OPTRUMA a produs cre teri semnificative ale densit ii osoase la nivelul oldului i al coloanei vertebrale, precum i ale masei minerale totale a corpului, în compara ie cu placebo.
This increase was generally a 2% increase in BMD compared to placebo.
Aceast cre tere a fost în general o cre tere cu 2% a DMO în compara ie cu placebo.
A similar increase in BMD was seen in the treatment population who received OPTRUMA for up to 7 years.
O cre tere similar a DMO s- a constatat la popula ia tratat ce a primit OPTRUMA timp de pân la 7 ani.
In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was: for the spine 37% decreased and 63% increased; and for the total hip 29% decreased and 71% increased.
În studiile de profilaxie, procentul de subiecte care au avut cre tere sau descre tere a DMO în cursul terapiei cu raloxifen a fost: pentru coloan 37% sc dere i 63% cre tere; iar pentru old total 29% sc dere i 71% cre tere.
OPTRUMA and oestrogen affect bone remodelling and calcium metabolism similarly.
OPTRUMA i estrogenii afecteaz asem n tor remodelarea osoas i metabolismul calciului.
OPTRUMA was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
OPTRUMA s- a asociat cu resorb ia redus a osului i cu o deplasare medie pozitiv în balan a de calciu de 60 mg pe zi, datorat în primul rând sc derii pierderilor urinare de calciu.
In a study comparing OPTRUMA with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Într- un studiu care a comparat OPTRUMA cu estrogenii, osul de la paciente tratate cu oricare din cele dou medicamente a fost normal histologic, f r semne de defecte de mineralizare, os între esut sau fibroz medular.
Raloxifene decreases resorption of bone; this effect on bone is manifested as reductions in the serum and urine levels of bone turnover markers, decreases in bone resorption based on radiocalcium kinetics studies, increases in BMD and decreases in the incidence of fractures.
Raloxifenul scade resorb ia osoas; acest efect asupra oaselor se manifest prin reduceri ale concentra iilor plasmatice i urinare ale markerilor turnover- ului osos, sc derea resorb iei osoase bazate pe studiile cineticii calciului marcat radioactiv, cre teri ale DMO i sc deri ale frecven ei fracturilor.
b) Effects on lipid metabolism and cardiovascular risk
b) Efecte asupra metabolismului lipidic i riscului cardiovascular
Clinical trials showed that a 60 mg daily dose of OPTRUMA significantly decreased total cholesterol (3 to 6%), and LDL cholesterol (4 to 10%).
Studiile clinice au ar tat c o doz de 60 mg pe zi de OPTRUMA a sc zut semnificativ colesterolul total (3% pân la 6%) i LDL- colesterolul (4% pân la 10%).
Women with the highest baseline cholesterol levels had the greatest decreases.
Femeile cu cele mai mari concentra ii ini iale de colesterol au avut cele mai mari sc deri.
HDL cholesterol and triglyceride concentrations did not change significantly.
Concentra iile HDL- colesterolului i ale trigliceridelor nu s- au modificat semnificativ.
After 3 years therapy OPTRUMA decreased fibrinogen (6.71%).
Dup 3 ani de tratament, OPTRUMA a sc zut fibrinogenul (6, 71%).
In the osteoporosis treatment study, significantly fewer OPTRUMA-treated patients required initiation of hypolipidaemic therapy compared to placebo.
În studiul de tratament al osteoporozei, semnificativ mai pu ine paciente tratate cu OPTRUMA au necesitat ini ierea unui tratament hipoliemiant, în compara ie cu placebo.
OPTRUMA therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Tratamentul cu OPTRUMA timp de 4 ani nu a afectat semnificativ riscul de evenimente cardiovasculare la pacientele înrolate în studiul tratamentului osteoporozei.
Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
4. 4 pentru cre terea riscului de accident vascular cerebral fatal).
8 The relative risk of venous thromboembolic events observed during raloxifene treatment was 1.60 (CI 0.95, 2.71) when compared to placebo, and was 1.0 (CI 0.3, 6.2) when compared to oestrogen or hormonal replacement therapy.
8 Riscul relativ al evenimentelor tromboembolice venoase observate în cursul tratamentului cu raloxifen a fost 1, 60 (IÎ 0, 95; 2, 71) în compara ie cu placebo i 1, 0 (IÎ 0, 3; 6, 2) în compara ie cu estrogenii sau cu tratamentul hormonal de substitu ie.
c) Effects on the endometrium and on the pelvic floor
c) Efectele asupra endometrului i plan eului pelvin
In clinical trials, OPTRUMA did not stimulate the postmenopausal uterine endometrium.
În studiile clinice, OPTRUMA nu a stimulat endometrul uterin postmenopauzal.
Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
În compara ie cu placebo, raloxifenul nu s- a asociat cu mici sânger ri, hemoragii vaginale sau hiperplazie endometrial.
Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Au fost evaluate aproape 3000 de examin ri ecografice transvaginale (TVU) de la 831 de femei din toate grupurile de dozaj.
Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo.
Femeile tratate cu raloxifen au avut constant o grosime a endometrului care nu a putut fi distins de cea din grupul placebo.