[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636523":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":10,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Natural Cycles","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NC° Users Participating in Study",null,"An individual who has recently registered to the Natural Cycles app will be screened based on the information routinely collected at registration and invited to the study if they meet specific screening criteria. After informed consent, the onboarding survey will explicitly verify further inclusion and exclusion criteria with participants.",[13,14],"Behavioral: Log daily intercourse information","Device: Natural Cycles application",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"BEHAVIORAL","Log daily intercourse information","For the duration of their participation in the study, participants will use the contraceptive app as usual but will be prompted to diligently log daily intercourse information and to regularly test for pregnancy. Upon exiting the study for any reason, all participants will complete a urine pregnancy test and an online Exit Questionnaire.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DEVICE","Natural Cycles application","Users will receive daily fertility status from Natural Cycles application",[9],[27,31],{"name":28,"affiliation":29,"role":30},"Eleonora Benhar, PhD","Natural Cycles Nordic AB","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":30},"Kristina Gemzell-Danielsson, PhD","Karolinska Institutet",[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Agathe van Lamsweerde, MSc","CONTACT","201-431-6036","venus_study@naturalcycles.com",[41],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Natural Cycles USA Corp","RECRUITING","New York","10036","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-74.00597,40.71427,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":38,"phoneExt":10,"email":39},"Megan Callanan",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100636523","validation-of-effectiveness-on-naturalcycles-users-100636523",false,"NCT07566793","Validation of Effectiveness on NaturalCycles Users","A Prospective Observational Study on the Contraceptive Effectiveness of the Natural Cycles Application (The VENUS Study)","VENUS","Inclusion Criteria:\n\n* Wants to avoid pregnancy for 13 cycles.\n* Is willing to rely solely on Natural Cycles as their sole contraception method for 13 cycles.\n* Is not currently using permanent contraceptive methods, such as sterilization (of either the user or their partner), or hormonal methods, such as the hormonal contraceptive implant or IUD.\n* Has an intact uterus, both ovaries and both fallopian tubes to the best of their knowledge.\n* Has an average cycle length between 21 and 35 days. The user anticipates heterosexual intercourse at least once a month in the next year.\n* Is willing to enter data on a daily basis and perform pregnancy tests as requested by protocol.\n* Is willing to complete a satisfaction survey at the end of her study participation.\n\nExclusion Criteria:\n\n* Has EU-citizenship\n* Has had a Depo-Provera injection in the last 10 months or has had less than three consecutive, spontaneous menstrual cycles since their last injection.\n* Has had less than three consecutive, spontaneous menstrual cycles after removing a hormonal implant.\n* Has had less than three consecutive, spontaneous menstrual cycles after the end of a pregnancy.\n* Has had less than three consecutive, spontaneous menstrual cycles since she last breastfed.\n* Has (or partner has) known fertility issues, such as infertility and sterilization, or have been advised by a healthcare professional that they may have difficulty conceiving for any reason.\n* Has a medical condition possibly impacting fertility, i.e. endometriosis, a history of Pelvic Inflammatory Disease (PID), significant uterine fibroids or adenomyosis, or another diagnosed medical condition that they have been told affects fertility.\n* Is regularly taking one of the following prescribed pharmaceutical medications known to be teratogenic (i.e., a medication that can cause birth defects):\n\nIsotretinoin (like Accutane, Absorica, Claravis, or Myorisan) for severe acne Valproic acid or divalproex sodium (like Depakote, Depakene, or Topamax) for seizures (epilepsy), migraines, or bipolar disorder Methotrexate (Trexall, Rheumatrex) or leflunomide (Arava) for autoimmune conditions ACE Inhibitors (like Lisinopril, Enalapril) or Angiotensin II Receptor Blockers (ARBs) (like Losartan, Valsartan) for high blood pressure or heart conditions Warfarin (Coumadin, Jantoven) for blood clot prevention","FEMALE","18 Years","35 Years",{"count":71,"type":72},2000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to measure the effectiveness of the Natural Cycles digital birth control application at preventing pregnancy in sexually active women aged 18 to 35 with no known history of infertility. The main questions it aims to answer are:\n\n* What is the pregnancy rate of the application over one year, for all users?\n* What is the pregnancy rate of the application over one year, for users who follow the application's instructions perfectly?\n\nParticipants will:\n\n* Use the Natural Cycles application for birth control for up to one year.\n* Log information about daily sexual activity in the app.\n* Complete a questionnaire at the beginning and end of their participation.\n* Perform urine pregnancy tests (provided by mail) upon entry to the study, at the start of every cycle during the study, and upon exit from the study.",[76],"Contraception","2026-06-30",{"date":79,"type":80},"2026-07-01","ACTUAL",{"date":82,"type":80},"2026-04-28",{"date":84,"type":72},"2027-12",{"name":5,"class":6},1]