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The primary objective of this study is to describe and assess participants' satisfaction with current vulvovaginal atrophy (VVA) treatment.
This study is designed as a multicenter, cross-sectional, descriptive, observational study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postmenopausal Women | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Post-menopausal women visiting gynecologists at Spanish public and private centers.
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Teknon | Barcelona | 08022 | Spain | |||
| Hospital Universitario de Guadalajara |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37099983 | Derived | Palacios S, Sanchez-Borrego R, Suarez Alvarez B, Lugo Salcedo F, Gonzalez Calvo AJ, Quijano Martin JJ, Cancelo MJ, Fasero M. Impact of vulvovaginal atrophy therapies on postmenopausal women's quality of life in the CRETA study measured by the Cervantes scale. Maturitas. 2023 Jun;172:46-51. doi: 10.1016/j.maturitas.2023.03.007. Epub 2023 Mar 30. |
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| Day 0 |
| 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 |
| 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 |
| 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 |
| Treatment Most Rejected by Patients According to the Opinion of the Healthcare Professional (HCP) | Day 0 |
| Preferred Route of Administration and Treatment Schedule in the Opinion of the HCP | Day 0 |
| 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 |
| 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 |
| HCP's Perception of Treatment Duration for Each Type of VVA Treatment | Day 0 |
| 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 |
| HCP´s Perception about Patient Non-compliance to Each of the VVA Treatments | Day 0 |
| Treatment Duration for Each Type of VVA Treatment According to the HCP and the Patient | Day 0 |
| Patients' Preferred Treatment, Route of Administration and Treatment Schedule According to the HCP | 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 |
| VVA Symptoms Acknowledged by the Patient | Day 0 |
| 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 |
| 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 | 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 |
| Importance Given by the Patient to Comply with the Treatment for VVA | Day 0 |
| 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 |
| Reasons for not Following HCP Instructions for Treatment of VVA | Day 0 |
| Importance Patient Gives to Follow the Instructions of her Doctor About the Treatment for VVA | Day 0 |
| Cervantes Quality of Life (QOL) Questionnaire Total Score and Domain Scores | 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 |
| Guadalajara |
| 19002 |
| Spain |
| Instituto Palacios | Madrid | 28009 | Spain |