Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments (CRETA)

Shionogi

Status: Completed

Conditions: Vulvovaginal Atrophy

Study type: Observational

Funder types: Industry

Identifiers

NCT04607707

CRETA

Details and patient eligibility

About

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

Full description

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

Enrollment: 831 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

831 participants in 1 patient group

Postmenopausal Women

Description:

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.