Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments

Vulvovaginal Atrophy Clinical Trial

— CRETA  

Official title:

Satisfaction and Treatment Adherence in Women With Vulvovaginal Atrophy: A Cross-sectional Study (CRETA Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607707
• Other study ID #: CRETA
• Status: Completed
• Start date: July 7, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 831
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Locations

Country	Name	City	State
Spain	Clínica Teknon	Barcelona
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Instituto Palacios	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception of Patient Satisfaction with Their Current Vulvovaginal Atrophy (VVA) Treatment by means of a questionnaire	The results will be determined by an evaluation the patient's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Primary	Perception of Patient Satisfaction with Long-term VVA Treatment of Vulvovaginal Atrophy by Means of a Questionnaire	The results will be determined by an evaluation the patient's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	Factors that the Patient Identifies as Advantages of VVA Treatment by Means of a Questionnaire	The results will be determined by an evaluation the patient's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	Factors that the Patient Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire	The results will be determined by an evaluation the patient's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	Preferred Route of Administration and Treatment Schedule for VVA Determined by a Questionnaire	The results will be determined by an evaluation the patient's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	Other Factors that Affect Adherence to VVA Treatment in the Patient´s Opinion as Determined by a Questionnaire	The results will be determined by an evaluation the patient's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	Treatment Most Rejected by Patients According to the Opinion of the Healthcare Professional (HCP)		Day 0
Secondary	Preferred Route of Administration and Treatment Schedule in the Opinion of the HCP		Day 0
Secondary	Factors the HCP Identifies as Advantages of VVA Treatment by Means of a Questionnaire	The results will be determined by an evaluation the HCP's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	Factors the HCP Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire	The results will be determined by an evaluation the HCP's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	HCP's Perception of Treatment Duration for Each Type of VVA Treatment		Day 0
Secondary	Other Factors that Influence Adherence According to the HCP Determined by Means of a Questionnaire	The results will be determined by an evaluation the HCP's selection of answers to questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	HCP´s Perception about Patient Non-compliance to Each of the VVA Treatments		Day 0
Secondary	Treatment Duration for Each Type of VVA Treatment According to the HCP and the Patient		Day 0
Secondary	Patients' Preferred Treatment, Route of Administration and Treatment Schedule According to the HCP		Day 0
Secondary	Factors that According to the HCP and the Patient Influence the Patient's Decision to Discontinue Treatment		Day 0
Secondary	Factors Positively Affecting the Patient's Adherence to Each Treatment According to the HCP and Patient		Day 0
Secondary	VVA Acknowledgement by the Patient		Day 0
Secondary	VVA Symptoms Acknowledged by the Patient		Day 0
Secondary	Satisfaction with Current VVA Treatment by means of a Questionnaire	The results will be determined by an evaluation the patient's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	Acknowledgement of the Advantages and Disadvantages of Treatment for VVA		Day 0
Secondary	Patient's Level of Compliance to the Treatment Scheme Prescribed by the HCP by Means of a Questionnaire	The results will be determined by an evaluation the patient's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	Importance Given by the Patient to Comply with the Treatment for VVA		Day 0
Secondary	Patient Compliance with HCP instructions Regarding the Treatment Dosage by Means of a Questionnaire	The results will be determined by an evaluation the patient's selection of answers to 32 questions designed to determine the patient's use of, compliance with, and satisfaction with treatments for vulvovaginal atrophy. The questions have answers on a 5-point scale with the lowest score for dissatisfaction and the highest score for satisfaction	Day 0
Secondary	Reasons for not Following HCP Instructions for Treatment of VVA		Day 0
Secondary	Importance Patient Gives to Follow the Instructions of her Doctor About the Treatment for VVA		Day 0
Secondary	Cervantes Quality of Life (QOL) Questionnaire Total Score and Domain Scores		Day 0
Secondary	Symptoms that Most Benefit from VVA Treatment According to the Patient		Day 0
Secondary	Time to Improvement in VVA Symptoms According to the Patient		Day 0
Secondary	Effect of Educational Level, Marital Status, Age, and Geographic Location on Treatment Adherence for VVA		Day 0