NCT04607707

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
831

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

September 22, 2020

Last Update Submit

June 18, 2021

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (28)

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

    Day 0

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

    Day 0

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

    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

  • +23 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post-menopausal women visiting gynecologists at Spanish public and private centers.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clínica Teknon

Barcelona, 08022, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Instituto Palacios

Madrid, 28009, Spain

Location

Related Publications (1)

  • 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.

    PMID: 37099983DERIVED

Study Officials

  • Shionogi Clinical Trials Administrator Clinical Support Help Line

    Shionogi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

October 29, 2020

Study Start

July 7, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Locations

ES(3)