Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments
- Conditions
- Vulvovaginal Atrophy
- Registration Number
- NCT04607707
- Lead Sponsor
- Shionogi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 831
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Perception of Patient Satisfaction with Long-term VVA Treatment of Vulvovaginal Atrophy by Means of a Questionnaire Day 0 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
Perception of Patient Satisfaction with Their Current Vulvovaginal Atrophy (VVA) Treatment by means of a questionnaire Day 0 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
- Secondary Outcome Measures
Name Time Method Reasons for not Following HCP Instructions for Treatment of VVA Day 0 Symptoms that Most Benefit from VVA Treatment According to the Patient Day 0 Time to Improvement in VVA Symptoms According to the Patient Day 0 Effect of Educational Level, Marital Status, Age, and Geographic Location on Treatment Adherence for VVA Day 0 Factors that the Patient Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire Day 0 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
Factors the HCP Identifies as Advantages of VVA Treatment by Means of a Questionnaire Day 0 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
HCP´s Perception about Patient Non-compliance to Each of the VVA Treatments Day 0 Patients' Preferred Treatment, Route of Administration and Treatment Schedule According to the HCP Day 0 Other Factors that Influence Adherence According to the HCP Determined by Means of a Questionnaire Day 0 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
Factors that According to the HCP and the Patient Influence the Patient's Decision to Discontinue Treatment Day 0 Factors Positively Affecting the Patient's Adherence to Each Treatment According to the HCP and Patient Day 0 VVA Acknowledgement by the Patient Day 0 Other Factors that Affect Adherence to VVA Treatment in the Patient´s Opinion as Determined by a Questionnaire Day 0 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
Treatment Most Rejected by Patients According to the Opinion of the Healthcare Professional (HCP) Day 0 VVA Symptoms Acknowledged by the Patient Day 0 Importance Patient Gives to Follow the Instructions of her Doctor About the Treatment for VVA Day 0 Factors that the Patient Identifies as Advantages of VVA Treatment by Means of a Questionnaire Day 0 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
Factors the HCP Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire Day 0 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
Treatment Duration for Each Type of VVA Treatment According to the HCP and the Patient Day 0 Satisfaction with Current VVA Treatment by means of a Questionnaire Day 0 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
Acknowledgement of the Advantages and Disadvantages of Treatment for VVA Day 0 Patient's Level of Compliance to the Treatment Scheme Prescribed by the HCP by Means of a Questionnaire Day 0 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
Importance Given by the Patient to Comply with the Treatment for VVA Day 0 Preferred Route of Administration and Treatment Schedule for VVA Determined by a Questionnaire Day 0 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
Preferred Route of Administration and Treatment Schedule in the Opinion of the HCP Day 0 HCP's Perception of Treatment Duration for Each Type of VVA Treatment Day 0 Patient Compliance with HCP instructions Regarding the Treatment Dosage by Means of a Questionnaire Day 0 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
Cervantes Quality of Life (QOL) Questionnaire Total Score and Domain Scores Day 0
Trial Locations
- Locations (3)
Clínica Teknon
🇪🇸Barcelona, Spain
Hospital Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Instituto Palacios
🇪🇸Madrid, Spain