NCT04607707已完成不适用
Satisfaction and Treatment Adherence in Women With Vulvovaginal Atrophy: A Cross-sectional Study (CRETA Study)
Shionogi3 个研究点 分布在 1 个国家目标入组 831 人开始时间: 2020年7月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 831
- 试验地点
- 3
- 主要终点
- Perception of Patient Satisfaction with Long-term VVA Treatment of Vulvovaginal Atrophy by Means of a Questionnaire
研究概览
简要总结
The primary objective of this study is to describe and assess participants' satisfaction with current vulvovaginal atrophy (VVA) treatment.
详细描述
This study is designed as a multicenter, cross-sectional, descriptive, observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Perception of Patient Satisfaction with Long-term VVA Treatment of Vulvovaginal Atrophy by Means of a Questionnaire
时间窗: 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
时间窗: 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
次要结局
- Factors that the Patient Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire(Day 0)
- Factors the HCP Identifies as Advantages of VVA Treatment by Means of a Questionnaire(Day 0)
- 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)
- 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)
- 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)
- Factors the HCP Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire(Day 0)
- 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)
- 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)
- Importance Given by the Patient to Comply with the Treatment for VVA(Day 0)
- 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)
- Preferred Route of Administration and Treatment Schedule for VVA Determined by a Questionnaire(Day 0)
- 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)
- Cervantes Quality of Life (QOL) Questionnaire Total Score and Domain Scores(Day 0)
- Effect of Educational Level, Marital Status, Age, and Geographic Location on Treatment Adherence for VVA(Day 0)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail LacquerFoot DermatosesNCT02679911Galderma R&D20
已完成
4 期
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%Foot DermatosesNCT02705664Galderma R&D22
已完成
不适用
Survey Conducted Among Early Breast Cancer Patients Treated With Arimidex for Evaluation of Treatment AdherenceBreast CancerNCT01081509AstraZeneca1,077
已完成
不适用
Patient Satisfaction in Cutaneous SurgerySkin CancerNCT01535963Northwestern University354
进行中（未招募）
1 期
Subject adherence and satisfaction for treatment of Onychomycosis with Loceryl® Nail Lacquer 5% versus Ciclopoli® Nail Lacquer.Toenail Distal and Lateral Subungual OnychomycosisMedDRA version: 18.0Level: PTClassification code 10030338Term: OnychomycosisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-001237-24-DEGalderma R&D20