Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-21 @ 5:16 PM
Study NCT ID:
NCT05300568
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2022-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Survey About Trade-offs When Choosing Menopause Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1465}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part-worth utilities for each treatment attribute', 'timeFrame': '1 day (once through survey)', 'description': "The effect of changes in each attribute on preferences.\n\nParticipants' preferences for Vasomotor Symptoms (VMS) treatment attributes will be collected via a discrete choice experiment (DCE).\n\nParticipants will be asked to choose their preferred option among two treatments or no treatment.\n\nNegative part-worth utility indicates less desired levels and positive part-worth utility indicates more desired levels of attributes."}, {'measure': 'Relative attribute importance scores', 'timeFrame': '1 day (once through survey)', 'description': 'Relative attribute importance scores will be derived from part-worth estimates and measure the maximum percentage contribution to a preference that relates to a change in each attribute.'}, {'measure': 'Maximum acceptable risk', 'timeFrame': '1 day (once through survey)', 'description': 'Maximum acceptable risk will be derived from part-worth estimates and measures how much risk (i.e., for each included risk) participants are willing to accept for a one-unit change in each other attribute.'}, {'measure': 'Minimum acceptable benefit', 'timeFrame': '1 day (once through survey)', 'description': 'Minimum acceptable benefit will be derived from part-worth estimates and measures the minimum acceptable reduction in the frequency of VMS for a unit change in each other attribute.'}], 'secondaryOutcomes': [{'measure': 'Estimated probability that a specific treatment profile will be chosen', 'timeFrame': '1 day (once through survey)', 'description': 'A set of treatment profiles will be generated using the attributes included in the discrete choice experiment (DCE). The probability of each profile being selected will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menopause', 'vasomotor symptoms'], 'conditions': ['Moderate to Severe Vasomotor Symptoms']}, 'descriptionModule': {'briefSummary': "This study is an online survey of women in menopause with moderate to severe hot flashes. Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.\n\nThis study is about collecting information only. There will be no treatment in this study. This study will provide information on the trade-offs women are willing to make when deciding which treatment or treatments work best for them.\n\nWomen from Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden and the United Kingdom (UK) will take part in this study.\n\nWomen will be recruited through a third-party recruitment company.\n\nMost women will be asked to complete an online survey. Before the survey is sent to the women in the study, it will be tested by a small group of women. This group will be asked to take part in a telephone interview while taking the survey. They will be asked to say their thoughts aloud while completing the survey. Researchers will record this and also take notes. The aim of the interview is to check that the survey is understood by the women before it is sent out to the rest of the women.\n\nThe survey will have 3 sections: Firstly, the women will answer questions about their experience with menopause and their symptoms. Next, they will be shown pros and cons for specific treatments for their menopause symptoms. The women will be asked to choose which treatment they would prefer, based on this information. Finally, they will answer questions on how their menopause symptoms have impacted their lives."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'post-menopausal women with moderate to severe VMS associated with menopause', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden, or the United Kingdom\n* Experience at least 14 moderate or severe VMS episodes associated with menopause per week (or 2 to 3 episodes per day)\n* Self-reported completion of natural menopause (post-menopausal)\n* Willing and able to provide consent to take part in the study; Speak native language of country of participation\n* Telephone interview only: Willing and able to participate in a telephone interview, and be audio recorded\n\nExclusion Criteria:\n\n* Experienced treatment related menopause either as a result of medical or surgical intervention\n* Difficulty understanding or communicating in the language(s) of Australia, Canada, Denmark, France, Italy, Spain, Sweden, or the United Kingdom\n* Online survey only: Participation in the Telephone interview'}, 'identificationModule': {'nctId': 'NCT05300568', 'briefTitle': 'A Survey About Trade-offs When Choosing Menopause Treatments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': "Women's Treatment Preferences for Moderate to Severe Vasomotor Symptoms (VMS) (WARMER Study)", 'orgStudyIdInfo': {'id': '2693-MA-3237'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'post-menopausal women', 'description': 'post-menopausal women with moderate to severe VMS associated with menopause', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'This is a non-product related survey.', 'armGroupLabels': ['post-menopausal women']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hammersmith', 'country': 'United Kingdom', 'facility': 'Site GB44001', 'geoPoint': {'lat': 51.49384, 'lon': -0.22882}}], 'overallOfficials': [{'name': 'Senior Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}