Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cimicifuga racemosa
The other group will have 30 patients receiving tamoxifen 20 mg orally daily or exemestane (aromatase inhibitor) 25 mg orally once daily after a meal and will start with 2 tablets per day of dry extract of Cimicifuga racemosa.
Each tablet contains 20 mg of dry extract of Cimicifuga racemosa standardized between 1 mg and 1.25 mg of triterpene glycosides expressed in 26-deoxyactein. Will be guided 1 tablet 12/12 hours for 6 months.
WHOQOL questionnaire (The World Health Organization Quality of life)application for evaluation at the first visit, 3-month and 6-month follow-up.
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
WHOQOL questionnaire
WHO defines Quality of Life as individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
FSFI questionnaire
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
kupperman scale
Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
Cimicifuga racemosa
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer
tamoxifen
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen
exemestane
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.
Control
Control group will have 30 patients receiving tamoxifen 20 mg orally daily or exemestane (aromatase inhibitor) 25 mg orally once daily after a meal . They will be followed for 6 months and answer Kupperman scale, WHOQOL questionnaire and FSFI questionnaire at the first visit, 3-month and 6-month follow-up.
WHOQOL questionnaire (The World Health Organization Quality of life)application for evaluation at the first visit, 3-month and 6-month follow-up.
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
WHOQOL questionnaire
WHO defines Quality of Life as individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
FSFI questionnaire
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
kupperman scale
Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
tamoxifen
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen
exemestane
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.
Interventions
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WHOQOL questionnaire
WHO defines Quality of Life as individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
FSFI questionnaire
FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
kupperman scale
Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
Cimicifuga racemosa
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer
tamoxifen
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen
exemestane
The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With hot flashes and with or without active sexual life.
Exclusion Criteria
* do not use tamoxifen or aromatase inhibitor
* not in menopause and not have hot flashes
48 Years
68 Years
FEMALE
Yes
Sponsors
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Irmandade da Santa Casa de Misericordia de Sao Paulo
OTHER
Responsible Party
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Carolina Furtado Macruz
Doctor
Principal Investigators
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Black cohosh
Role: PRINCIPAL_INVESTIGATOR
Irmandade da Santa Casa Misericordia Sao Paulo
Locations
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Carolina Furtado Macruz
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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349441
Identifier Type: -
Identifier Source: org_study_id
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