Nctid:
NCT06230770
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006470", "term"=>"Hemorrhage"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M9556", "name"=>"Hemorrhage", "asFound"=>"Bleeding", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M16509", "name"=>"Testosterone", "relevance"=>"LOW"}, {"id"=>"M14244", "name"=>"Progestins", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>160}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-15", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-17", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Mean days bleeding or spotting", "timeFrame"=>"Start of GATT to 30 days", "description"=>"mean number of days of bleeding or spotting during the 30 days after GATT initiation"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["progestin", "testosterone", "gender-affirming", "bleeding"], "conditions"=>["Gender", "Contraception"]}, "descriptionModule"=>{"briefSummary"=>"Gender diverse individuals who use gender-affirming testosterone therapy (GATT) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. Research is limited, however, regarding expected bleeding patterns for individuals who choose to initiate GATT concurrently with a progestin. Clinicians who prescribe GATT do not have sufficient data to adequately counsel patients on side effects of concurrent progestin use and therefore extrapolate from studies conducted in cisgender women. This study is a prospective cohort study evaluating bleeding patterns and satisfaction among patients initiating GATT with or without concurrent initiation of a progestin contraceptive. The results from this study will enable clinicians to more accurately counsel patients using GATT on how the use of a progestin might affect their bleeding and whether this differs by progestin method."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"We will enroll 160 participants who are English-speaking, at least 18 years old, currently have a uterus and ovaries, desire to initiate GATT, and potentially desire to initiate a progestin (within 14 days of GATT initiation). To ensure generalizability of results, participants with baseline irregular bleeding will not be excluded.\n\nParticipants who have recently initiated a progestin may be eligible for inclusion. Participants who have had gender-affirming surgery to remove their uterus and/or ovaries will not be eligible for inclusion.\n\nWe will recruit participants from clinics in San Diego that prescribe GATT, including the UCSD OBGYN clinic, two UCSD Gender Health program affiliated clinics, and UCSD Student Health Services.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* English-speaking currently have a uterus and ovaries\n* desire to initiate GATT\n* potential desire to initiate a progestin (within 14 days of GATT initiation)\n\nExclusion Criteria:\n\n* previous gender-affirming surgery to remove their uterus and/or ovaries"}, "identificationModule"=>{"nctId"=>"NCT06230770", "briefTitle"=>"Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating GATT", "organization"=>{"class"=>"OTHER", "fullName"=>"University of California, San Diego"}, "officialTitle"=>"The Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating Testosterone Therapy for Gender Affirmation", "orgStudyIdInfo"=>{"id"=>"809057"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Bleeding data", "type"=>"BEHAVIORAL", "description"=>"Participants will report their daily bleeding patterns"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92037", "city"=>"San Diego", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"University of California San Diego", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}], "centralContacts"=>[{"name"=>"Marisa Hildebrand, MPH", "role"=>"CONTACT", "email"=>"mchildeb@health.ucsd.edu", "phone"=>"8582243319"}, {"name"=>"Kelsey Loeliger, MD, PhD", "role"=>"CONTACT", "email"=>"kloeliger@health.ucsd.edu"}], "overallOfficials"=>[{"name"=>"Kelsey Loeliger, MD. PhD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"UC San Diego"}, {"name"=>"Sarah Averbach, MD, MSc", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"UC San Diego"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of California, San Diego", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor", "investigatorFullName"=>"Sarah Averbach, MD MAS", "investigatorAffiliation"=>"University of California, San Diego"}}}}
