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Completed

NCT Number: NCT04607707

Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments

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

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Key information

Conditions

Vulvovaginal Atrophy

Sex eligibility

Female

Study type

Observational

Primary location

Clínica Teknon, Barcelona, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Perception of Patient Satisfaction with Their Current Vulvovaginal Atrophy (VVA) Treatment by means of a questionnaire

    Time frame: 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

  2. Perception of Patient Satisfaction with Long-term VVA Treatment of Vulvovaginal Atrophy by Means of a Questionnaire

    Time frame: 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 outcomes

  1. Factors that the Patient Identifies as Advantages of VVA Treatment by Means of a Questionnaire

    Time frame: 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

  2. Factors that the Patient Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire

    Time frame: 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

  3. Preferred Route of Administration and Treatment Schedule for VVA Determined by a Questionnaire

    Time frame: 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

  4. Other Factors that Affect Adherence to VVA Treatment in the Patient´s Opinion as Determined by a Questionnaire

    Time frame: 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

  5. Treatment Most Rejected by Patients According to the Opinion of the Healthcare Professional (HCP)

    Time frame: Day 0

  6. Preferred Route of Administration and Treatment Schedule in the Opinion of the HCP

    Time frame: Day 0

  7. Factors the HCP Identifies as Advantages of VVA Treatment by Means of a Questionnaire

    Time frame: 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

  8. Factors the HCP Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire

    Time frame: 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

  9. HCP's Perception of Treatment Duration for Each Type of VVA Treatment

    Time frame: Day 0

  10. Other Factors that Influence Adherence According to the HCP Determined by Means of a Questionnaire

    Time frame: 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

  11. HCP´s Perception about Patient Non-compliance to Each of the VVA Treatments

    Time frame: Day 0

  12. Treatment Duration for Each Type of VVA Treatment According to the HCP and the Patient

    Time frame: Day 0

  13. Patients' Preferred Treatment, Route of Administration and Treatment Schedule According to the HCP

    Time frame: Day 0

  14. Factors that According to the HCP and the Patient Influence the Patient's Decision to Discontinue Treatment

    Time frame: Day 0

  15. Factors Positively Affecting the Patient's Adherence to Each Treatment According to the HCP and Patient

    Time frame: Day 0

  16. VVA Acknowledgement by the Patient

    Time frame: Day 0

  17. VVA Symptoms Acknowledged by the Patient

    Time frame: Day 0

  18. Satisfaction with Current VVA Treatment by means of a Questionnaire

    Time frame: 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

  19. Acknowledgement of the Advantages and Disadvantages of Treatment for VVA

    Time frame: Day 0

  20. Patient's Level of Compliance to the Treatment Scheme Prescribed by the HCP by Means of a Questionnaire

    Time frame: 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

  21. Importance Given by the Patient to Comply with the Treatment for VVA

    Time frame: Day 0

  22. Patient Compliance with HCP instructions Regarding the Treatment Dosage by Means of a Questionnaire

    Time frame: 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

  23. Reasons for not Following HCP Instructions for Treatment of VVA

    Time frame: Day 0

  24. Importance Patient Gives to Follow the Instructions of her Doctor About the Treatment for VVA

    Time frame: Day 0

  25. Cervantes Quality of Life (QOL) Questionnaire Total Score and Domain Scores

    Time frame: Day 0

  26. Symptoms that Most Benefit from VVA Treatment According to the Patient

    Time frame: Day 0

  27. Time to Improvement in VVA Symptoms According to the Patient

    Time frame: Day 0

  28. Effect of Educational Level, Marital Status, Age, and Geographic Location on Treatment Adherence for VVA

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

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

Acronym: CRETA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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