Vulvovaginal AtrophyCRETANCT04607707
Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments
An observational study of Vulvovaginal Atrophy, run by Shionogi at 3 sites in Spain.
Trial summary
The primary objective of this study is to describe and assess participants' satisfaction with current vulvovaginal atrophy (VVA) treatment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- How many people
- 831 participants
- Where
- 3 sitesSpain
- Study dates
- 7 Jul 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Post-menopausal women visiting gynecologists at Spanish public and private centers.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Clínica Teknon
Barcelona, 08022
Hospital Universitario de Guadalajara
Guadalajara, 19002
Instituto Palacios
Madrid, 28009
About this study
Official title: Satisfaction and Treatment Adherence in Women With Vulvovaginal Atrophy: A Cross-sectional Study (CRETA Study)
The primary objective of this study is to describe and assess participants' satisfaction with current vulvovaginal atrophy (VVA) treatment.
Read the detailed description
This study is designed as a multicenter, cross-sectional, descriptive, observational study.
- Conditions
- Vulvovaginal Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 0
Secondary outcomes (28)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0
Treatment Most Rejected by Patients According to the Opinion of the Healthcare Professional (HCP)
Measured: Day 0
Preferred Route of Administration and Treatment Schedule in the Opinion of the HCP
Measured: 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
Measured: 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
Measured: Day 0
HCP's Perception of Treatment Duration for Each Type of VVA Treatment
Measured: 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
Measured: Day 0
HCP´s Perception about Patient Non-compliance to Each of the VVA Treatments
Measured: Day 0
Treatment Duration for Each Type of VVA Treatment According to the HCP and the Patient
Measured: Day 0
Patients' Preferred Treatment, Route of Administration and Treatment Schedule According to the HCP
Measured: Day 0
Factors that According to the HCP and the Patient Influence the Patient's Decision to Discontinue Treatment
Measured: Day 0
Factors Positively Affecting the Patient's Adherence to Each Treatment According to the HCP and Patient
Measured: Day 0
VVA Acknowledgement by the Patient
Measured: Day 0
VVA Symptoms Acknowledged by the Patient
Measured: 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
Measured: Day 0
Acknowledgement of the Advantages and Disadvantages of Treatment for VVA
Measured: 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
Measured: Day 0
Importance Given by the Patient to Comply with the Treatment for VVA
Measured: 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
Measured: Day 0
Reasons for not Following HCP Instructions for Treatment of VVA
Measured: Day 0
Importance Patient Gives to Follow the Instructions of her Doctor About the Treatment for VVA
Measured: Day 0
Cervantes Quality of Life (QOL) Questionnaire Total Score and Domain Scores
Measured: Day 0
Symptoms that Most Benefit from VVA Treatment According to the Patient
Measured: Day 0
Time to Improvement in VVA Symptoms According to the Patient
Measured: Day 0
Effect of Educational Level, Marital Status, Age, and Geographic Location on Treatment Adherence for VVA
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start7 Jul 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal AtrophyStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607707
- Sponsor's protocol ID
- CRETA
- Acronym
- CRETA
- Status last verified
- Jun 2021
- First submitted
- 22 Sep 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37099983
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction and Treatment Adherence in Women With Vulvovaginal Atrophy: A Cross-sectional Study (CRETA Study)
- ClinicalTrials.gov ID
- NCT04607707
- Acronym / sponsor ID
- CRETA / CRETA
- Conditions
- Vulvovaginal Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Post-menopausal women visiting gynecologists at Spanish public and private centers.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
28 secondary outcomes
Factors that the Patient Identifies as Advantages of VVA Treatment by Means of a Questionnaire
Time frame: Day 0
Factors that the Patient Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire
Time frame: Day 0
Preferred Route of Administration and Treatment Schedule for VVA Determined by a Questionnaire
Time frame: Day 0
Other Factors that Affect Adherence to VVA Treatment in the Patient´s Opinion as Determined by a Questionnaire
Time frame: Day 0
Treatment Most Rejected by Patients According to the Opinion of the Healthcare Professional (HCP)
Time frame: Day 0
Preferred Route of Administration and Treatment Schedule in the Opinion of the HCP
Time frame: Day 0
Factors the HCP Identifies as Advantages of VVA Treatment by Means of a Questionnaire
Time frame: Day 0
Factors the HCP Identifies as Disadvantages of VVA Treatment by Means of a Questionnaire
Time frame: Day 0
HCP's Perception of Treatment Duration for Each Type of VVA Treatment
Time frame: Day 0
Other Factors that Influence Adherence According to the HCP Determined by Means of a Questionnaire
Time frame: Day 0
HCP´s Perception about Patient Non-compliance to Each of the VVA Treatments
Time frame: Day 0
Treatment Duration for Each Type of VVA Treatment According to the HCP and the Patient
Time frame: Day 0
Patients' Preferred Treatment, Route of Administration and Treatment Schedule According to the HCP
Time frame: Day 0
Factors that According to the HCP and the Patient Influence the Patient's Decision to Discontinue Treatment
Time frame: Day 0
Factors Positively Affecting the Patient's Adherence to Each Treatment According to the HCP and Patient
Time frame: Day 0
VVA Acknowledgement by the Patient
Time frame: Day 0
VVA Symptoms Acknowledged by the Patient
Time frame: Day 0
Satisfaction with Current VVA Treatment by means of a Questionnaire
Time frame: Day 0
Acknowledgement of the Advantages and Disadvantages of Treatment for VVA
Time frame: Day 0
Patient's Level of Compliance to the Treatment Scheme Prescribed by the HCP by Means of a Questionnaire
Time frame: Day 0
Importance Given by the Patient to Comply with the Treatment for VVA
Time frame: Day 0
Patient Compliance with HCP instructions Regarding the Treatment Dosage by Means of a Questionnaire
Time frame: Day 0
Reasons for not Following HCP Instructions for Treatment of VVA
Time frame: Day 0
Importance Patient Gives to Follow the Instructions of her Doctor About the Treatment for VVA
Time frame: Day 0
Cervantes Quality of Life (QOL) Questionnaire Total Score and Domain Scores
Time frame: Day 0
Symptoms that Most Benefit from VVA Treatment According to the Patient
Time frame: Day 0
Time to Improvement in VVA Symptoms According to the Patient
Time frame: Day 0
Effect of Educational Level, Marital Status, Age, and Geographic Location on Treatment Adherence for VVA
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Derived from this study: PubMed 37099983Palacios 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvovaginal Atrophy, run by Shionogi at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of Patient Satisfaction with Their Current Vulvovaginal Atrophy (VVA) Treatment by means of a questionnaire (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.