Clinical trial NCT04607707: Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments
Official title: Satisfaction and Treatment Adherence in Women With Vulvovaginal Atrophy: A Cross-sectional Study (CRETA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvovaginal Atrophy
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 831
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal women visiting gynecologists at Spanish public and private centers.

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Perception of Patient Satisfaction with Their Current Vulvovaginal Atrophy (VVA) Treatment by means of a questionnaire
timeFrame: Day 0
measure: Perception of Patient Satisfaction with Long-term VVA Treatment of Vulvovaginal Atrophy by Means of a Questionnaire
timeFrame: Day 0
Secondary outcomes:
measure: Factors that the Patient Identifies as Advantages of VVA Treatment by Means of a Questionnaire
timeFrame: Day 0
measure: Factors that the Patient Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire
timeFrame: Day 0
measure: Preferred Route of Administration and Treatment Schedule for VVA Determined by a Questionnaire
timeFrame: Day 0
measure: Other Factors that Affect Adherence to VVA Treatment in the Patient´s Opinion as Determined by a Questionnaire
timeFrame: Day 0
measure: Treatment Most Rejected by Patients According to the Opinion of the Healthcare Professional (HCP)
timeFrame: Day 0
measure: Preferred Route of Administration and Treatment Schedule in the Opinion of the HCP
timeFrame: Day 0
measure: Factors the HCP Identifies as Advantages of VVA Treatment by Means of a Questionnaire
timeFrame: Day 0
measure: Factors the HCP Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire
timeFrame: Day 0
measure: HCP's Perception of Treatment Duration for Each Type of VVA Treatment
timeFrame: Day 0
measure: Other Factors that Influence Adherence According to the HCP Determined by Means of a Questionnaire
timeFrame: Day 0
measure: HCP´s Perception about Patient Non-compliance to Each of the VVA Treatments
timeFrame: Day 0
measure: Treatment Duration for Each Type of VVA Treatment According to the HCP and the Patient
timeFrame: Day 0
measure: Patients' Preferred Treatment, Route of Administration and Treatment Schedule According to the HCP
timeFrame: Day 0
measure: Factors that According to the HCP and the Patient Influence the Patient's Decision to Discontinue Treatment
timeFrame: Day 0
measure: Factors Positively Affecting the Patient's Adherence to Each Treatment According to the HCP and Patient
timeFrame: Day 0
measure: VVA Acknowledgement by the Patient
timeFrame: Day 0
measure: VVA Symptoms Acknowledged by the Patient
timeFrame: Day 0
measure: Satisfaction with Current VVA Treatment by means of a Questionnaire
timeFrame: Day 0
measure: Acknowledgement of the Advantages and Disadvantages of Treatment for VVA
timeFrame: Day 0
measure: Patient's Level of Compliance to the Treatment Scheme Prescribed by the HCP by Means of a Questionnaire
timeFrame: Day 0
measure: Importance Given by the Patient to Comply with the Treatment for VVA
timeFrame: Day 0
measure: Patient Compliance with HCP instructions Regarding the Treatment Dosage by Means of a Questionnaire
timeFrame: Day 0
measure: Reasons for not Following HCP Instructions for Treatment of VVA
timeFrame: Day 0
measure: Importance Patient Gives to Follow the Instructions of her Doctor About the Treatment for VVA
timeFrame: Day 0
measure: Cervantes Quality of Life (QOL) Questionnaire Total Score and Domain Scores
timeFrame: Day 0
measure: Symptoms that Most Benefit from VVA Treatment According to the Patient
timeFrame: Day 0
measure: Time to Improvement in VVA Symptoms According to the Patient
timeFrame: Day 0
measure: Effect of Educational Level, Marital Status, Age, and Geographic Location on Treatment Adherence for VVA
timeFrame: Day 0
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clínica Teknon
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References: