Public trial
RBR-88vgp6 Effects of soy beans isoflavone in the vagina and the uterum in the post menopausal womens
Date of registration: 01/04/2012 (mm/dd/yyyy)Last approval date : 01/04/2012 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Effects of Glycine max (L.) Merr in the vaginal epitelium and the endometrium in post menopausal women
pt-br
Efeitos das isoflavonas do Glycine max (L.) Merr no epitelio vaginal e no endometrio em mulheres apos a menopausa
Trial identification
- UTN code: U1111-1122-9186
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Public title:
en
Effects of soy beans isoflavone in the vagina and the uterum in the post menopausal womens
pt-br
Efeitos das isoflavonas da soja na vagina e no utero em mulheres apos a menopausa
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Scientific acronym:
-
Public acronym:
-
Secondaries identifiers:
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093/10
Issuing authority: CEP-FCMSCSP
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093/10
Sponsors
- Primary sponsor: FACULDADE DE CIÊNCIAS MÉDICAS DA SANTA CASA DE SÃO PAULO
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Secondary sponsor:
- Institution: FACULDADE DE CIÊNCIAS MÉDICAS DA SANTA CASA DE SÃO PAULO
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Supporting source:
- Institution: FACULDADE DE CIÊNCIAS MÉDICAS DA SANTA CASA DE SÃO PAULO
Health conditions
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Health conditions:
en
Vaginal atrophy Menopause Treatment Women
pt-br
Atrofia vaginal Menopausa Tratamento Mulheres
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General descriptors for health conditions:
en
N00-N99 XIV - Diseases of the genitourinary system
pt-br
N00-N99 XIV - Doenças do aparelho geniturinário
en
C13 Female urogenital diseases and pregnancy complications
pt-br
C13 Doenças urogenitais femininas e complicações na gravidez
es
C13 Enfermedades urogenitales femeninas y complicaciones del embarazo
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Specific descriptors:
Interventions
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Interventions:
en
Group 1: 30 women in use of intravaginal gel with Glycine max (L.) Merr isoflavone, 1 gr/day/90 dias. Group 2: 30 women in use of intravaginal gel placebo, 1gr/day/90 days
pt-br
Grupo 1: 30 mulheres com aplicacao de gel vaginal com isoflavona do Glycine max (L.) Merr, 1g via vaginal ao dia por 90 dias e Grupo 2: 30 mulheres com aplicacao de gel placebo, 1g via vaginal ao dia por 90 dias
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Descriptors:
en
A05.360.319.779 Vagina
pt-br
A05.360.319.779 Vagina
es
A05.360.319.779 Vagina
Recruitment
- Study status: recruitment completed
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Countries
- Brazil
- Date first enrollment: 01/01/2011 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 60 F 45 Y 68 Y -
Inclusion criteria:
en
Women with age 45-68 years old Vaginal atrophy simptons Menopause >12 months With out hot flushes No contraindications for hormonal terapy
pt-br
Mulheres com idade entre 45 e 68 anos Com sintomas de atrofia vaginal Com pelo menos 12 meses de menopausa Sem ondas de calor Sem contra-indicacao para terapia hormonal Sem uso de Terapia Hormonal
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Exclusion criteria:
en
Hot flushes symptons Breast neoplasy and endomtrium With Hormonal teraphy
pt-br
Queixas de ondas de calor Neoplasia maligna da mama, endometrio Indicacao a terapia hormonal
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase treatment parallel 3 single-blind randomized-controlled 4
Outcomes
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Primary outcomes:
en
The vaginal atrophy symptons with isoflavone gel will be less than placebo gel. The maturation index of vaginal citology will going to evaluated and by transvaginal ultrasonography the endometrium will going to evaluated
pt-br
Os sintomas de atrofia vaginal serao menores com o uso de gel de isoflavona em comparacao com o placebo. Serao avaliados a citologia hormonal vaginal atraves do indice de maturacao celular e o endometrio atraves da ultrassonografia
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Secondary outcomes:
en
There should be an increase in the number of the vaginal cells in use of isoflavone gel
pt-br
Deverá haver o aumento do número de células do epitélio vaginal em uso do gel de isoflavona
Contacts
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Public contact
- Full name: silvia saito
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- Address: rua Dr cesario motta junior, 61
- City: sao paulo / Brazil
- Zip code: 01221-020
- Phone: 11 36677833
- Email: sisaito@hotmail.com
- Affiliation: faculdade de ciencias medicas da santa casa de sao paulo
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Scientific contact
- Full name: silvia saito
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- Address: rua Dr Cesario motta junior, 61
- City: sao paulo / Brazil
- Zip code: 01221-020
- Phone: 11 36677833
- Email: sisaito@hotmail.com
- Affiliation: faculdade de ciencias medicas da santa casa de sao paulo
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Site contact
- Full name: silvia saito
-
- Address: rua Dr cesario motta junior, 61
- City: sao paulo / Brazil
- Zip code: 01221-020
- Phone: 11 36677833
- Email: sisaito@hotmail.com
- Affiliation: faculdade de ciencias medicas da santa casa de sao paulo
Additional links:
Total de Ensaios Clínicos 17440.
Existem 8770 ensaios clínicos registrados.
Existem 4835 ensaios clínicos recrutando.
Existem 90 ensaios clínicos em análise.
Existem 5881 ensaios clínicos em rascunho.