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F156 Lack of microbial proliferation and phototoxic potential of a new oestradiol matrix patch (Estraderm MX®)
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F154
EFFICACY AND TOLE~B~LITY OF A NEW OESTRADLOL MATRIX PATCH (EST~DERM MX@ 50) IN THE TREATMENT OF MODERATE-TO-SEVERE HOT FLUSHES
PG Crosimtatd,D deAloysio2,R Pisati”, GE Hiils’: on behalfof The EstradermMX StudyGroup. ‘I Dept. of Obstetrics & Gynecology University of Milan; ‘III Dept. of Obstetrics& Gynecology,Bologna; 3Ciba-GeigySpA, Italy; “Xnt. Chin. I&s., Ciba-GeigyLtd, Baste.
EFFICACY AND TOLERABILITY BENEFITS OF NEW MATRIX PATCHES (EST~DERM MX@ 50 AND 100) IN THE TREATMENT OF MODERATE-TO-SEVERE POSTMENOPAUSAL SYMPTOMS
MPM. ~nii~l~rs~AL T~o~s~~~, HS T/S&,AHJAM van Bu~r~n4, G Monzas, on behalfof TheEstraderm MX StudyGroup.I St. MaartensGastkuis. Venlo, 2De Wee~en~~den, Zwolle, 3St. GeminiZiekenkuis,Den Hclder,4Ciba,Arnhem,TheNetherlands, SCiba,Saronno,Italy.
This double-blind, randomised,parallel-group 12 weeks study comparedthe efficacy and tolerabiIity of a new matrix patch This double-blind,randomised,placebocontrolled, parallelgroup, (EstradermMX) appliedtwice weekly with a delivery rateof 50 pg 12-weekstudy examinedthe efficacy and tolerability of Estraderm oestradiolper day, with placebo in 109 women suffering from MX patchesappliedtwice weekly, with a delivery rate of 50 pg and modemte-to-severe pos~enopausals~ptoms. The meannumber 100 pg oes&radiol per day in 254 womenwith moderate-to-severe of moderate-to-severe hot flushesper 24 hoursfor EstradermMX postmenopausal symptoms. The mean number of moderate-topatientswas significantly lower than in patientson placeboat all severehot flushesper 24 hours(includingnight sweats)during the time-points. The estimateddifferencebetweenthe EsfradermMX last2 weeksof treatmentwassignificantly lower in the Estraderm group and the placebogroup after 12 weekswas4.2 hot flushes MX 50 and 100 treatmentgroupsthan in the placebogroup (p < (95% CI 2.6 to 5,8; p < 0.001). The KuppermanIndex valueswere 0.00I). Thetreatmentgroupcontrastsof the differencefrom baseline alsosigni~cantIylowerin theEstradermMX groupat all time points aRer12weekswere: 5.0 for EstradermMX 50-placebo,and 5.3 for EstradermMX LOO-placebo. EstradermMX 50 and IO0 were also (p < 0.001).The adverseeventsweresimilarin both groups. After 12 weeksthe percentageof patientsexperiencingskin irritation by statisticallysignificantlysuperiorto placeboat all time-points(p< direct questioningwas20% in the EstradermMX groupand22% in 0.001) with respectto the frequency of hot flushes and the the pIacebogroup. In conclusion,this new matrix patch offers a Kuppe~~ Index. At 12 weeksthe propo~ion of patients on well tolerated meansof oestradioldelivery for postmenopausal EstradermMX 100 and on EstradermMX 50 reporting no skin irritation at all was 72% and 71% respectively. A slight dosewomen. dependent increase in oestrogen-relatedside-effects (breast tenderness, vaginalbleeding)wasseenwith EstradermMX 100. In conclusion,this newmatrix patchsystemoffersaneffective andwell toleratedmeansof delivering50 pg and 100pg oestradrolper day.
F156
IF155 EFFICACY AND TOLERABILITY OF A NEW LOW DOSE MATRIX PATCH (EST~DE~ MX@ 25) IN THE TREATMENT OF MILD-TO-MODERATE MENOPAUSAL SYMPTOMS.
LACK OF MICROBIAL PROLIFERATION AND PHOTOTOXIC POTENTIAL OF A NEW OEST~DIOL MATRIX PATCH (ESTRADERM MX@)
GE ~~1s’GDelia-Cloaca’,BS Brrger?$BA Harp&, LMf Oel&ft4. ‘Ciba-GeigyLtd, Switzerland;2Ciba-GeigyCorp,NJ, USA; 3HiIItop 0 ChevalIiet( D Keil’, GE Htiid, CC Monza” ‘Boulevard Saint Germain,Paris France, ‘Amselweg, Schorndorf Biolabs Inc., Cincinnati, OH, USA; “The Hilltop Companies, Germany,31nt. Clinical Research,Ciba-GeigyLtd, Switzerland, Cincinnati,OH, USA. 4Ciba-GeigySpA, Italy The potential of EstradermMX to causemicrobial proliferation This doubly-blind,r~domised, placebo-controlled,12-weekstudy under the occluded site or acute phototoxicity reactions was examinedthe efficacy and tolerability of Es~adermMX 25 ~witk a investigatedin 2 singIe-blind,placebo-controIledstudies. In tke delivery rate of 25 pg oestradiolper day) in 133womenwith mild- microbialproliferationstudy (A) 20 healthypostmenopausal women to-moderatemenopausal symptoms. The KuppermanIndex at the wore I EstradermMX patchandI placebopatchfor 4 days. In the last visit was si8ni~c~tly lower (p=O.OOZ)in the EstradermMX pkototoxici~ study (B), 11 subjectswore 2 EstraderrnMX and 2 groupthan in tke placebogroup. Mean differencesin Kupperman placebopatchesfor 8 hours. One hour after the removalof I active Index betweenthe 2 treatmentgroups were already statistically and 1 placebopatch, the exposedsiteswere irradiatedwith UVA signi~c~t at 4 and 8 weeks(p < 0.05). Lesspatientson Estraderm radiationand visible light. In study A, the total aerobicbacterial MX experiencedmoderate/severe vaginal dryness(9.9%) than in populationshowedan increasein meancountsof < I log,, from placebo (I 9.1%; p=O.153). The mostfrequentlypossibly/probably baselineto post-removalwith both placeboand active patches drug-relatedadverseexperiencesreported was breasttenderness (Williamson and Kligman technique). In study B, no patient (16% for EstradermMX, 7% for placebo). Overall, 81% of the experienceda &in reactionof morethan grade1 (= mild reaction). EstradetmMX 25 groupand 90%of the placebogroupreportedno In conclusion,thesetwo studiesindicatethat EstradermMX patches erythemaat the siteof patchapplication.Therewasnot a singIecase do not promotemicrobialproliferationunderthe occludedpatchsite of moderate-to-severe or severeerytkema. In conclusion,25 ug of or causeacutephototox~ci~following removal. oestradiol per day effectively controls mild-to-moderate postmenopausal symptoms.This low dosenew matrix patch offers an efftcacious and well tolerated meansof mild-to-moderate postmenopausal symptomcontrol.
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F154
EFFICACY AND TOLE~B~LITY OF A NEW OESTRADLOL MATRIX PATCH (EST~DERM MX@ 50) IN THE TREATMENT OF MODERATE-TO-SEVERE HOT FLUSHES
PG Crosimtatd,D deAloysio2,R Pisati”, GE Hiils’: on behalfof The EstradermMX StudyGroup. ‘I Dept. of Obstetrics & Gynecology University of Milan; ‘III Dept. of Obstetrics& Gynecology,Bologna; 3Ciba-GeigySpA, Italy; “Xnt. Chin. I&s., Ciba-GeigyLtd, Baste.
EFFICACY AND TOLERABILITY BENEFITS OF NEW MATRIX PATCHES (EST~DERM MX@ 50 AND 100) IN THE TREATMENT OF MODERATE-TO-SEVERE POSTMENOPAUSAL SYMPTOMS
MPM. ~nii~l~rs~AL T~o~s~~~, HS T/S&,AHJAM van Bu~r~n4, G Monzas, on behalfof TheEstraderm MX StudyGroup.I St. MaartensGastkuis. Venlo, 2De Wee~en~~den, Zwolle, 3St. GeminiZiekenkuis,Den Hclder,4Ciba,Arnhem,TheNetherlands, SCiba,Saronno,Italy.
This double-blind, randomised,parallel-group 12 weeks study comparedthe efficacy and tolerabiIity of a new matrix patch This double-blind,randomised,placebocontrolled, parallelgroup, (EstradermMX) appliedtwice weekly with a delivery rateof 50 pg 12-weekstudy examinedthe efficacy and tolerability of Estraderm oestradiolper day, with placebo in 109 women suffering from MX patchesappliedtwice weekly, with a delivery rate of 50 pg and modemte-to-severe pos~enopausals~ptoms. The meannumber 100 pg oes&radiol per day in 254 womenwith moderate-to-severe of moderate-to-severe hot flushesper 24 hoursfor EstradermMX postmenopausal symptoms. The mean number of moderate-topatientswas significantly lower than in patientson placeboat all severehot flushesper 24 hours(includingnight sweats)during the time-points. The estimateddifferencebetweenthe EsfradermMX last2 weeksof treatmentwassignificantly lower in the Estraderm group and the placebogroup after 12 weekswas4.2 hot flushes MX 50 and 100 treatmentgroupsthan in the placebogroup (p < (95% CI 2.6 to 5,8; p < 0.001). The KuppermanIndex valueswere 0.00I). Thetreatmentgroupcontrastsof the differencefrom baseline alsosigni~cantIylowerin theEstradermMX groupat all time points aRer12weekswere: 5.0 for EstradermMX 50-placebo,and 5.3 for EstradermMX LOO-placebo. EstradermMX 50 and IO0 were also (p < 0.001).The adverseeventsweresimilarin both groups. After 12 weeksthe percentageof patientsexperiencingskin irritation by statisticallysignificantlysuperiorto placeboat all time-points(p< direct questioningwas20% in the EstradermMX groupand22% in 0.001) with respectto the frequency of hot flushes and the the pIacebogroup. In conclusion,this new matrix patch offers a Kuppe~~ Index. At 12 weeksthe propo~ion of patients on well tolerated meansof oestradioldelivery for postmenopausal EstradermMX 100 and on EstradermMX 50 reporting no skin irritation at all was 72% and 71% respectively. A slight dosewomen. dependent increase in oestrogen-relatedside-effects (breast tenderness, vaginalbleeding)wasseenwith EstradermMX 100. In conclusion,this newmatrix patchsystemoffersaneffective andwell toleratedmeansof delivering50 pg and 100pg oestradrolper day.
F156
IF155 EFFICACY AND TOLERABILITY OF A NEW LOW DOSE MATRIX PATCH (EST~DE~ MX@ 25) IN THE TREATMENT OF MILD-TO-MODERATE MENOPAUSAL SYMPTOMS.
LACK OF MICROBIAL PROLIFERATION AND PHOTOTOXIC POTENTIAL OF A NEW OEST~DIOL MATRIX PATCH (ESTRADERM MX@)
GE ~~1s’GDelia-Cloaca’,BS Brrger?$BA Harp&, LMf Oel&ft4. ‘Ciba-GeigyLtd, Switzerland;2Ciba-GeigyCorp,NJ, USA; 3HiIItop 0 ChevalIiet( D Keil’, GE Htiid, CC Monza” ‘Boulevard Saint Germain,Paris France, ‘Amselweg, Schorndorf Biolabs Inc., Cincinnati, OH, USA; “The Hilltop Companies, Germany,31nt. Clinical Research,Ciba-GeigyLtd, Switzerland, Cincinnati,OH, USA. 4Ciba-GeigySpA, Italy The potential of EstradermMX to causemicrobial proliferation This doubly-blind,r~domised, placebo-controlled,12-weekstudy under the occluded site or acute phototoxicity reactions was examinedthe efficacy and tolerability of Es~adermMX 25 ~witk a investigatedin 2 singIe-blind,placebo-controIledstudies. In tke delivery rate of 25 pg oestradiolper day) in 133womenwith mild- microbialproliferationstudy (A) 20 healthypostmenopausal women to-moderatemenopausal symptoms. The KuppermanIndex at the wore I EstradermMX patchandI placebopatchfor 4 days. In the last visit was si8ni~c~tly lower (p=O.OOZ)in the EstradermMX pkototoxici~ study (B), 11 subjectswore 2 EstraderrnMX and 2 groupthan in tke placebogroup. Mean differencesin Kupperman placebopatchesfor 8 hours. One hour after the removalof I active Index betweenthe 2 treatmentgroups were already statistically and 1 placebopatch, the exposedsiteswere irradiatedwith UVA signi~c~t at 4 and 8 weeks(p < 0.05). Lesspatientson Estraderm radiationand visible light. In study A, the total aerobicbacterial MX experiencedmoderate/severe vaginal dryness(9.9%) than in populationshowedan increasein meancountsof < I log,, from placebo (I 9.1%; p=O.153). The mostfrequentlypossibly/probably baselineto post-removalwith both placeboand active patches drug-relatedadverseexperiencesreported was breasttenderness (Williamson and Kligman technique). In study B, no patient (16% for EstradermMX, 7% for placebo). Overall, 81% of the experienceda &in reactionof morethan grade1 (= mild reaction). EstradetmMX 25 groupand 90%of the placebogroupreportedno In conclusion,thesetwo studiesindicatethat EstradermMX patches erythemaat the siteof patchapplication.Therewasnot a singIecase do not promotemicrobialproliferationunderthe occludedpatchsite of moderate-to-severe or severeerytkema. In conclusion,25 ug of or causeacutephototox~ci~following removal. oestradiol per day effectively controls mild-to-moderate postmenopausal symptoms.This low dosenew matrix patch offers an efftcacious and well tolerated meansof mild-to-moderate postmenopausal symptomcontrol.
91