Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments
NCT ID: NCT04607707
Last Updated: 2021-06-21
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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COMPLETED
831 participants
OBSERVATIONAL
2020-07-07
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Postmenopausal Women
Participants who sign an informed consent will be asked to complete study questionnaires at a single visit that coincides with a normal healthcare visit. No other study procedures will be performed.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Absence of menstruation for at least one year.
* Mild, moderate or severe VVA diagnosis.
* Currently under treatment with either Ospemifene, Local Oestrogen Therapy or moisturizers for at least 3 months in accordance with the approved SmPC and/or Patient Leaflet
* Patients providing writing informed consent for participating in the study.
Exclusion Criteria
* Women who have discontinued their VVA treatment due to a contraindication in the study group drug.
* Patients using more than one VVA treatment at a time (except for lubricants).
* Breastfeeding, pregnancy or under any kind of systemic hormonal treatment that causes amenorrhea.
* Local phytotherapy for VVA.
FEMALE
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Principal Investigators
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Locations
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ClĂnica Teknon
Barcelona, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Instituto Palacios
Madrid, , Spain
Countries
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References
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Palacios S, Sanchez-Borrego R, Suarez Alvarez B, Lugo Salcedo F, Gonzalez Calvo AJ, Quijano Martin JJ, Cancelo MJ, Fasero M. Impact of vulvovaginal atrophy therapies on postmenopausal women's quality of life in the CRETA study measured by the Cervantes scale. Maturitas. 2023 Jun;172:46-51. doi: 10.1016/j.maturitas.2023.03.007. Epub 2023 Mar 30.
Other Identifiers
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CRETA
Identifier Type: -
Identifier Source: org_study_id
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