FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with suspected breast cancer or patients undergoing active treatment (including adjuvant therapy) for breast cancer (see section 4.4).
Slovenian: Bolnice s sumom na raka na dojki ali bolnice, ki se aktivno zdravijo zaradi raka na dojki (vključno z adjuvantno terapijo) (glejte poglavje 4.4).
English: The mean age of participants was 61.7 years in the ospemifene 60 mg group and 62.9 years in the placebo group.
Slovenian: Povprečna starost udeleženk je bila 61,7 let za skupino z ospemifenom 60 mg in 62,9 let za skupino s placebom.
English: No cases of endometrial hyperplasia were reported at either time point.
Slovenian: V nobeni časovni točki niso poročali o primerih hiperplazije endometrija.
English: No data are available on its concomitant use with medicinal products used in the treatment of early or advanced breast cancer.
Slovenian: Podatki o sočasni uporabi z zdravili, ki se uporabljajo za zdravljenje raka dojke v zgodnji fazi ali napredovalega raka dojke, niso na voljo.
English: Effects of other medicinal products on ospemifene
Slovenian: Učinek drugih zdravil na ospemifen
English: Renal clearance of unchanged active substance is a minor pathway of elimination, less than 0.2% of the ospemifene dose is excreted unchanged in urine.
Slovenian: Ledvični očistek nespremenjene učinkovine je manj pomembna pot izločanja, saj se manj kot 0,2% odmerka ospemifena nespremenjenega izloči v urinu.
English: Therefore, caution is recommended when ospemifene is combined with orlistat.
Slovenian: Zato se priporoča previdnost, če se ospemifen kombinira z orlistatom.
English: - If you are unable to walk for a long time or are sitting for a long time in the same position because of major surgery, injury or illness, it may prevent good blood circulation and may temporarily increase your risk of blood clots.
Slovenian: Med jemanjem zdravila Senshio: - Če dlje časa ne morete hoditi ali dlje časa sedite v istem položaju zaradi večje operacije, poškodbe ali bolezni, lahko to prepreči dober krvni obtok in začasno poveča tveganje za nastanek krvnih strdkov.
English: - If your doctor thinks you might have or you are being treated for cancer which is sensitive to oestrogens, such as cancer of the womb.
Slovenian: - če vaš zdravnik meni, da imate ali se zdravite zaradi raka, občutljivega na estrogen, kot je rak maternice.
English: “Substantial improvement” was restricted to patients who had moderate or severe MBS at baseline and changed from severe to mild or severe or moderate to none.
Slovenian: „Bistveno izboljšanje“ je bilo omejeno na bolnice, ki so imele ob izhodišču zmerni ali resen MBS in pri katerih se je ocena spremenila iz hude v blaga ali hude v zmerno ali brez simptoma.
English: A trend was observed in both trials in the improvement of MBS from baseline to week 4 in favour of ospemifene compared to placebo, although the difference was not statistically significant.
Slovenian: V obeh preskušanjih so opazili trend v izboljšanju MBS od izhodišča do 4. tedna v korist ospemifena v primerjavi s placebom, čeprav razlika ni bila statistično značilna.
English: This is known as vulvar and vaginal atrophy.
Slovenian: To je znano kot atrofija vulve in vagine.
English: EU/1/14/978/001 EU/1/14/978/002 EU/1/14/978/003
Slovenian: EU/1/14/978/002
English: Senshio has no known or very little influence on the ability to drive and use machines.
Slovenian: Zdravilo Senshio nima znanega vpliva ali ima zelo majhen vpliv na sposobnost vožnje in upravljanja strojev.
English: The long-term study (trial 3) was a 52-week, randomised, double-blind, placebo-controlled safety and efficacy study in 426 postmenopausal women with an intact uterus.
Slovenian: Dolgoročna študija (preskušanje 3) je bila 52-tedenska randomizirana, dvojno slepa, s placebom kontrolirana študija varnosti in učinkovitosti pri 426 ženskah po menopavzi z neokrnjeno maternico.
English: There are no data on the use of ospemifene in pregnant women.
Slovenian: Podatkov o uporabi ospemifena pri nosečnicah ni.
English: - If you experience signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, difficulty in breathing or a stroke while taking Senshio, stop taking Senshio and see a doctor immediately.
Slovenian: - Če se pojavijo znaki krvnih strdkov, kot so boleča oteklina ali rdečina nog, nenadna bolečina v prsnem košu, težave z dihanjem ali možganska kap, takoj prenehajte jemati zdravilo Senshio in pojdite k zdravniku.
English: No clinically important pharmacokinetic differences between subjects with severe renal impairment and healthy subjects were observed.
Slovenian: Klinično pomembnih razlik v farmakokinetiki med osebami s hudo ledvično okvaro in zdravimi osebami niso opazili.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino (učinkovine) ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: If a dose is missed it should be taken with food as soon as the patient remembers.
Slovenian: Če bolnica pozabi vzeti tableto, jo naj vzame skupaj s hrano takoj, ko se spomni.
English: It is unknown if ospemifene is a substrate for BCRP in the intestine.
Slovenian: Ni znano, ali je ospemifen v črevesju substrat za BCRP.
English: Plasma/blood cell partitioning of [14C]-Ospemifene (< 3%) and [14C]-4-hydroxyospemifene (< 2%) is low.
Slovenian: Porazdelitev [14C]-ospemifena (< 3%) in [14C]-4-hidroksiospemifena (< 2%) med plazmo in krvnimi celicami je majhna.
English: Cerebro-vascular events
Slovenian: Cerebrovaskularni dogodki
English: Ospemifene-related changes included ovarian follicular cysts, endometrial stromal atrophy and endometrial hypertrophy/hyperplasia which are consistent with the pharmacologic activity of ospemifene in the intact, normally cycling animal.
Slovenian: Spremembe, povezane z ospemifenom, so vključevale folikularne ciste na jajčnikih, stromalno atrofijo endometrija in hipertrofijo/hiperplazijo endometrija, kar je skladno s farmakološko aktivnostjo ospemifena pri živalih z intaktnim, normalnim ciklom.
English: Taken together, the liver changes observed in experimental animals in repeat dose toxicity studies are regarded as adaptive changes due to enzyme induction and given the lack of any clinical signs are unlikely to represent a safety concern for humans.
Slovenian: Povzeto velja, da so spremembe na jetrih, ki so jih opazili pri eksperimentalnih živalih v študijah toksičnosti pri ponavljajočih odmerkih, prilagoditvene spremembe zaradi indukcije encimov; ker ni nobenih kliničnih znakov, pa ni verjetno, da bi predstavljale skrb za varnost pri ljudeh.
English: Carbamazepine and phenytoin used to treat convulsions/seizures (anticonvulsants).
Slovenian: o Karbamazepin in fenitoin, ki se uporabljata za zdravljenje konvulzij/epileptičnih napadov (antikonvulzanti).
English: In the liver hepatocyte hypertrophy or increased glycogen storage, increase in alanine aminotransferase (ALT) and alkaline phosphatase (ALP) were observed.
Slovenian: Pri hipertrofiji jetrnih hepatocitov ali povečanem kopičenju glikogena so opazili povečanje alanin aminotransferaze (ALT) in alkalne fosfataze (ALP).
English: The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective estrogen receptor modulators (SERMs).
Slovenian: Tveganje za VTE (globoka venska tromboza in pljučna embolija) se poveča z drugimi selektivnimi modulatorji estrogenskih receptorjev (SERM, selective estrogen receptor modulators).
English: In those trials, a total of 1,102 subjects received 60 mg of ospemifene and 787 subjects received placebo.
Slovenian: V teh preskušanjih je skupaj 1.102 oseb prejemalo 60 mg ospemifena in 787 oseb je prejemalo placebo.
English: Do not take Senshio with any of these medicines:
Slovenian: Ne jemljite zdravila Senshio s katerim od naslednjih zdravil:
English: Therefore ospemifene should be used for the treatment of VVA only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Slovenian: Ospemifen se zato lahko za zdravljenje VVA uporablja le po končanem zdravljenju raka dojke, vključno z adjuvantnim zdravljenjem.
English: In patients with severe renal impairment the ospemifene exposure was increased by approximately 20%, when compared to healthy matched subjects.
Slovenian: Pri bolnicah s hudo ledvično okvaro se je izpostavljenost ospemifenu povečala za približno 20% v primerjavi s kontrolno skupino zdravih oseb.
English: These non-clinical findings are consistent with findings from clinical trials, in which ospemifene demonstrated benefits on vaginal physiology without apparent oestrogen-like effects on breast tissue (see subheading Clinical safety).
Slovenian: Ti predklinični izsledki so skladni s kliničnimi preskušanji, v katerih je ospemifen pokazal koristi na fiziologijo nožnice brez očitnega estrogenu podobnega učinka na tkivo dojke (glejte podnaslov Klinična varnost).
English: This should be considered when prescribing ospemifene for postmenopausal women with a history of stroke or other significant stroke risk factors.
Slovenian: To je treba upoštevati pri predpisovanju ospemifena ženskam po menopavzi z možgansko kapjo v anamnezi ali drugimi pomembnimi dejavniki za možgansko kap.
English: Endometrial findings
Slovenian: Izsledki preiskav na endometriju
English: Overall, tumour development in these studies is believed to be the result of rodent specific hormonal mechanisms when treated during their reproductive lives; these findings are unlikely to have any clinical relevance in postmenopausal women.
Slovenian: Prevladuje splošno mnenje, da je razvoj tumorjev v teh študijah rezultat hormonskega mehanizma, specifičnega za glodavce, ki so jim zdravilo dajali v reproduktivnem obdobju življenja; ni verjetno, da bi imeli ti izsledki kakršen koli klinični pomen pri ženskah po menopavzi.
English: The apparent total body clearance is 9.16 l/hr using a population approach.
Slovenian: Pri populacijskem pristopu je bil navidezni skupni telesni očistek 9,16 l/uro.
English: Co-administration with fluconazole
Slovenian: Sočasna uporaba ospemifena s flukonazolom
English: In two separate 12 week pivotal trials (trials 1 and 2), ospemifene was associated with a statistically significant mean decrease from baseline in the percentage of parabasal cells and vaginal pH and a statistically significant mean increase from baseline in the percentage of superficial cells, compared with placebo (P<0.001 for each parameter) at weeks 4 and 12.
Slovenian: V dveh ločenih 12-tedenskih ključnih preskušanjih (preskušanji 1 in 2) je bil ospemifen povezan s statistično značilnim povprečnim zmanjšanjem od izhodišča v odstotku parabazalnih celic in nožničnega pH in s statistično značilnim povprečnim povečanjem od izhodišča v odstotku površinskih celic v primerjavi s placebom (P < 0,001 za vsak parameter) v 4. in 12. tednu.
English: Oestrogens.
Slovenian: • Estrogeni.
English: The safety of using ospemifene concomitantly with oestrogens or other SERMS, such as tamoxifen, toremifene, bazedoxifene and raloxifene, has not been studied and its concurrent use is not recommended.
Slovenian: Varnosti ospemifena pri sočasni uporabi z estrogeni ali drugimi SERM, kot so tamoksifen, toremifen, bazedoksifen in raloksifen, niso preučili, zato se sočasna uporaba ne priporoča.
English: Ospemifene is not indicated for fertile women.
Slovenian: Ospemifen ni indiciran za ženske v plodni dobi.
English: Mean ospemifene Cmax and AUC0-24hr were 785 ng/mL and 5,448 ng•hr/mL, respectively, after repeat doses of 60 mg ospemifene once daily in the fed state.
Slovenian: Povprečna Cmax in AUC0-24hr ospemifena sta bili 785 ng/ml oz. 5.448 ng•uro/ml po ponavljajočih odmerkih 60 mg ospemifena enkrat na dan s hrano.
English: The principal radioactive component in both plasma and faeces was ospemifene and the main metabolite 4hydroxyospemifene.
Slovenian: Glavni radioaktivni komponenti v plazmi in blatu sta bili ospemifen in glavni presnovek 4-hidroksiospemifen.
English: Of the 426 subjects enrolled in the study, 363 (85.2%) subjects were randomised to once-daily oral doses of ospemifene 60 mg and 63 (14.8%) subjects were randomised to placebo.
Slovenian: Med 426 osebami, vključenimi v študijo, je bilo 363 (85,2%) oseb randomiziranih v skupino, ki je enkrat na dan prejemala peroralne odmerke ospemifena 60 mg, 63 (14,8%) oseb pa je bilo randomiziranih v skupino, ki je prejemala placebo.
English: No dose adjustment is necessary in elderly patients.
Slovenian: Prilagajanje odmerka za starejše bolnice ni potrebno.
English: The risk of cerebrovascular events associated with ospemifene cannot be excluded.
Slovenian: Tveganja za cerebrovaskularne dogodke, povezane z ospemifenom, ni mogoče izključiti.
English: Adverse reactions are listed below by MedDRA preferred term system organ class and by frequency.
Slovenian: Neželeni učinki so spodaj razvrščeni po prednostnih izrazih in organskih sistemih MedDRA in pogostnosti.
English: The relative contribution of the metabolite to the pharmacological effect is estimated to be approximately 40%.
Slovenian: Relativni doprinos presnovka k farmakološkem učinku je ocenjen na približno
English: Once you have started on Senshio you should see your doctor for regular check-ups (at least once a year).
Slovenian: Opozorila in previdnostni ukrepi Ko se začnete zdraviti z zdravilom Senshio, morate hoditi na redne preglede k zdravniku (vsaj enkrat na leto).
English: - If you have unexplained vaginal bleeding.
Slovenian: - če imate nepojasnjene krvavitve iz nožnice.
English: Therefore, co-administration of ospemifene with strong enzyme inducers like carbamazepine, phenytoin, St John's wort and rifabutin would be expected to decrease the exposure of ospemifene, which may decrease the clinical effect.
Slovenian: Zato je pričakovati, da bi sočasna uporaba ospemifena z močnimi induktorji encimov, kot so karbamazepin, fenitoin, šentjanževka in rifabutin, zmanjšala izpostavljenost ospemifenu, kar lahko zmanjša klinični učinek.
English: Unexplained vaginal bleeding.
Slovenian: Nepojasnjena krvavitev iz nožnice.
English: - If you have or have ever had a blood clot in a vein (thrombosis), for example, in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis).
Slovenian: - če imate ali ste kadar koli imeli strdek v žili (trombozo), na primer v nogah (globoka venska tromboza), pljučih (pljučna embolija) ali očesih (tromboza očesne mrežnice).
English: Endometrial safety in women was assessed at baseline and 12 weeks in the two 12-week phase III studies (trials 1 and 2: ospemifene, n=302; placebo, n= 301).
Slovenian: Varnost za endometrij pri ženskah so ocenili ob izhodišču in v 12. tednu v dveh 12-tedenskih študijah III. faze (preskušanji 1 in 2: ospemifen, n = 302; placebo, n = 301).
English: When ospemifene is administered with a high fat meal, the Cmax and AUC are 2.5-fold and 1.9-fold higher, respectively, with lower variability relative to the fasting state.
Slovenian: Pri jemanju ospemifena z obrokom z visoko vsebnostjo maščob je Cmax večji za 2,5-krat in AUC za 1,9-krat, spremenljivost pa je v primerjavi z uporabo na tešče manjša.
English: In the mammary gland, they have a predominantly oestrogen antagonist effect.
Slovenian: V mlečni žlezi imajo predvsem antagonistični učinek na estrogen.
English: If pregnancy occurs during treatment with ospemifene, ospemifene should be withdrawn immediately.
Slovenian: Če se med zdravljenjem z ospemifenom pojavi nosečnost, je treba ospemifen takoj prenehati uporabljati.
English: If VTE develops after initiating therapy, the treatment should be discontinued.
Slovenian: Če se VTE razvije po začetku zdravljenja, je treba z zdravljenjem takoj prenehati.
English: About 1% of subjects discontinued in the Phase 2/3 clinical programme due to hot flushes.
Slovenian: Približno 1% oseb je klinični program 2./3.
English: For the treatment of vulvar and vaginal atrophy, ospemifene should only be initiated for symptoms that adversely affect quality of life e.g. dyspareunia and vaginal dryness.
Slovenian: Za zdravljenje vulvarne in vaginalne atrofije se lahko ospemifen uvede le zaradi simptomov, ki slabo vplivajo na kakovost življenja, npr. disparevnijo in suhost nožnice.
English: Pre-existing gynaecological pathology other than signs of vaginal atrophy There are limited clinical trial data on the use of ospemifene in patients with other gynaecological conditions.
Slovenian: Obstoječa ginekološka patologija razen znakov atrofije vagine Pri bolnicah z drugimi ginekološkimi boleznimi so podatki iz kliničnih preskušanj glede uporabe ospemifena omejeni.
English: There were no abnormal breast palpation findings in the placebo group at baseline or at study end.
Slovenian: Nenormalnih izsledkov palpitacije v skupini s placebom ob izhodišču ali ob koncu študije ni bilo.
English: Senshio is used to treat women with moderate to severe post-menopausal symptoms in and outside the vagina, such as itching, dryness, burning and pain during sex (dyspareunia) if local oestrogen therapy is not suitable.
Slovenian: Zdravilo Senshio se uporablja za zdravljenje žensk z zmernimi do hudimi pomenopavznimi simptomi v nožnici in izven nje, kot so srbečica, suhost, skelenje in boleči spolni odnosi (disparevnija), če zdravljenje z lokalnim estrogenom ni primerno.
English: Table 1: Primary efficacy analysis - change from baseline to week 12 in most bothersome symptom (ITT, LOCF)
Slovenian: Preglednica 1: Analiza primarne učinkovitosti - sprememba najbolj motečega simptoma od izhodišča do 12. tedna (ITT, LOCF)
English: Other medicines and Senshio
Slovenian: Druga zdravila in zdravilo Senshio
English: In addition, these changes can result in chronic symptoms associated with VVA, the most common of which are vaginal dryness and dyspareunia.
Slovenian: Te spremembe lahko povzročijo tudi kronične simptome, povezane z VVA, med katerima sta najpogostejša suhost nožnice in disparevnija.
English: This medicine is not recommended if you have severely reduced liver function.
Slovenian: Bolnice z boleznijo jeter To zdravilo se ne priporoča, če imate hudo zmanjšano delovanje jeter.
English: Ospemifene did not cause a clinically meaningful change in the exposure to the substrates, indicating that ospemifene does not affect those enzyme activities in vivo to a clinically significant extent.
Slovenian: Ospemifen ni povzročil klinično pomembnih sprememb izpostavljenosti substratom, kar kaže na to, da ospemifen ne vpliva na aktivnosti encimov in vivo v klinično pomembnem obsegu.
English: Pack sizes of 7, 28 or 84 film-coated tablets.
Slovenian: Velikosti pakiranja so 7, 28 ali 84 filmsko obloženih tablet.
English: In clinical studies, a mean increase of 0.8 mm in endometrial thickness after 12 months (as assessed by protocol-specified ultrasonography) was observed and there was no increase in vaginal bleeding or spotting in the ospemifene-treated group compared to the placebo-treated group.
Slovenian: V kliničnih študijah so po 12 mesecih opazili povprečno odebelitev endometrija za 0,8 mm (ocenjeno z ultrazvokom, kot določa protokol), pojav krvavitev ali krvavkastega izcedka iz nožnice pa se v skupini, zdravljeni z ospemifenom ni povečal v primerjavi s skupino, ki je dobivala placebo.
English: They are packed in blisters and are available in pack sizes of 7, 28 or 84 film-coated tablets.
Slovenian: Pakirane so v pretisne omote in na voljo v velikostih pakiranja 7, 28 ali 84 filmsko obloženih tablet.
English: This increase is not considered to be clinically significant given the inherent pharmacokinetic variability of ospemifene.
Slovenian: To povečanje ne velja kot klinično pomembno glede na inherentno farmakokinetično variabilnost ospemifena.
English: In a two-generation reproductive study on pre-and postnatal development ospemifene induced an increased post-implantation loss, an increased number of dead pups at birth as well as an increased incidence of postnatal loss of pups in the F1 generation.
Slovenian: V študiji sposobnosti razmnoževanja, kjer so v dveh generacijah spremljali vpliv na razvoj pred rojstvom in po njem, je ospemifen povzročil povečanje izgube po implantaciji, večje število mrtvorojenih mladičev in večjo incidenco izgube mladičev po rojstvu v generaciji F1.
English: The risk of VTE associated with ospemifene cannot be excluded.
Slovenian: Tveganja za VTE, povezane z ospemifenom, ni mogoče izključiti.
English: Based on a review of data from clinical trials and post-marketing reporting, the PRAC considers that a causal relationship between ospemifene and the adverse reaction vaginal bleeding cannot be ruled out and therefore recommends an updated to section 4.8 of the SmPC.
Slovenian: Na podlagi pregleda podatkov iz kliničnih preskušanj in poročanja v obdobju trženja zdravila PRAC meni, da ni mogoče izključiti vzročne povezave med ospemifenom in neželenim učinkom "vaginalna krvavitev", zato priporoča posodobitev poglavja 4.8 povzetka glavnih značilnosti zdravila.
English: - If your doctor thinks you might have breast cancer or you are being treated for breast cancer.
Slovenian: - če zdravnik sumi, da imate raka na dojki ali se zdravite zaradi raka na dojki.
English: The glycogen content of vaginal epithelial cells also decreases, resulting in reduced colonisation by lactobacilli and increased vaginal pH.
Slovenian: Zmanjša se tudi vsebnost glikogena v epitelijskih celicah nožnice, kar povzroči zmanjšanje kolonizacije laktobacilov in povečanje pH nožnice.
English: The clinical efficacy and safety of ospemifene was determined primarily from two multi-centre, placebo-controlled trials of 12 weeks duration (trials 1 and 2) and a third long-term safety trial of 52 weeks duration (trial 3) in post-menopausal patients with VVA.
Slovenian: Klinična učinkovitost in varnost ospemifena sta bili prvenstveno ugotovljeni v dveh multicentričnih, s placebom kontroliranih preskušanjih, ki sta trajali 12 tednov (preskušanje 1 in 2) in v tretjem dolgoročnem preskušanju varnosti, ki je trajalo 52 tednov (preskušanje 3) pri bolnicah po menopavzi z VVA.
English: Shionogi B.V. Tel/Tel./Te./Tlf/Tél/Puh/Sími/ :
Slovenian: Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ: contact@shionogi.eu
English: The most bothersome symptom (MBS) was assessed at baseline, 4 and 12 weeks with the severity scored as follows: None=0, Mild=1, Moderate=2, Severe=3.
Slovenian: Najbolj moteč simptom (MBS) je bil ocenjen ob izhodišču in v 4. in 12. tednu z naslednjimi ocenami resnosti: brez = 0, blagi = 1, zmeren = 2, resen = 3.
English: Paediatric population Pharmacokinetic studies have not been performed with ospemifene in the paediatric population.
Slovenian: Pediatrična populacija Z ospemifenom niso izvajali farmakokinetičnih študij pri pediatrični populaciji.
English: No dose adjustment is necessary in patients above the age of 65 years (see section 5.2).
Slovenian: Pri bolnicah, starih več kot 65 let, odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Caution is recommended when co-administering ospemifene with fluconazole (see section 4.5).
Slovenian: Pri sočasni uporabi ospemifena s flukonazolom je potrebna previdnost (glejte poglavje 4.5).
English: For subjects completing the trial 1 extension study (ospemifene, n=41; placebo, n= 18) and for subjects in the long-term 52-week safety study (trial 3: ospemifene, n=276; placebo, n=46), endometrial safety was assessed by endometrial biopsy at baseline and at 12 months.
Slovenian: Za osebe, ki so dokončale podaljšano študijo preskušanja 1 (ospemifen, n = 41; placebo, n = 18) in za osebe v dolgoročni 52-tedenski študiji varnosti (preskušanje 3: ospemifen, n = 276; placebo, n = 46), je bila varnost za endometrij ocenjena z biopsijo endometrija ob izhodišču in v 12. mesecu.
English: Table 1 shows the mean change in severity score in MBS after 12 weeks with the associated statistical testing for the difference vs. placebo for trials 1 and 2.
Slovenian: V preglednici 1 je prikazana povprečna sprememba v rezultatu resnosti MBS po 12. tednih s povezanim statističnim testiranjem za razliko v primerjavi s placebom za preskušanje 1 in 2.
English: These changes result in clinical signs which include vaginal dryness, redness, petechiae, pallor, and friability in the mucosa.
Slovenian: Te spremembe povzročijo klinične znake, ki vključujejo suho in pordelo nožnico, petehije, bledico in krhkost sluznice.