Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments

NCT ID: NCT04607707

Last Updated: 2021-06-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

831 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-07

Study Completion Date

2021-04-30

Brief Summary

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The primary objective of this study is to describe and assess participants' satisfaction with current vulvovaginal atrophy (VVA) treatment.

Detailed Description

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This study is designed as a multicenter, cross-sectional, descriptive, observational study.

Conditions

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Vulvovaginal Atrophy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

* Women with natural menopause established for at least one year.
* 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 never been previously treated for VVA
* 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shionogi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Site Status

Instituto Palacios

Madrid, , Spain

Site Status

Countries

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Spain

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.

Reference Type DERIVED
PMID: 37099983 (View on PubMed)

Other Identifiers

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CRETA

Identifier Type: -

Identifier Source: org_study_id

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