{"id":"paragard","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Increased menstrual bleeding and cramping"},{"rate":"10-20","effect":"Spotting between periods"},{"rate":"5-15","effect":"Pelvic pain or discomfort"},{"rate":"2-5","effect":"Expulsion of device"},{"rate":"<1","effect":"Perforation of uterus"}]},"_chembl":null,"_dailymed":{"setId":"3c420b53-c95e-46af-aebd-73741be58391","title":"PARAGARD T 380A (COPPER) INTRAUTERINE DEVICE [COOPERSURGICAL, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The device releases copper ions that are spermicidal and create an inflammatory response in the uterus that is hostile to sperm survival and embryo implantation. This multi-mechanism approach provides long-acting reversible contraception without hormonal effects. The copper-mediated mechanism is non-hormonal, making it suitable for users who cannot tolerate or prefer to avoid hormonal contraceptives.","oneSentence":"ParaGard is a copper-containing intrauterine device (IUD) that prevents pregnancy by creating a toxic environment for sperm and inhibiting fertilization and implantation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:59:47.937Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Contraception in women of reproductive age"}]},"trialDetails":[{"nctId":"NCT03785366","phase":"PHASE3","title":"A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs)","status":"COMPLETED","sponsor":"Sebela Women's Health Inc.","startDate":"2018-12-17","conditions":"Women at Risk for Pregnancy","enrollment":41},{"nctId":"NCT03124160","phase":"PHASE3","title":"Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard","status":"COMPLETED","sponsor":"FHI 360","startDate":"2017-05-26","conditions":"Healthy Women, Female Contraception","enrollment":1105},{"nctId":"NCT05309694","phase":"PHASE4","title":"A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)","status":"COMPLETED","sponsor":"CooperSurgical Inc.","startDate":"2022-03-04","conditions":"Contraception","enrollment":119},{"nctId":"NCT02357368","phase":"PHASE4","title":"Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk","status":"COMPLETED","sponsor":"Lisa Haddad","startDate":"2015-02","conditions":"HIV, Contraception","enrollment":59},{"nctId":"NCT01299116","phase":"PHASE4","title":"Long-Acting Reversible Contraception","status":"COMPLETED","sponsor":"FHI 360","startDate":"2011-12","conditions":"Contraception","enrollment":916},{"nctId":"NCT02391714","phase":"NA","title":"Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion","status":"COMPLETED","sponsor":"University of New Mexico","startDate":"2013-10","conditions":"Contraception","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ParaGard T 380A"],"phase":"marketed","status":"active","brandName":"ParaGard®","genericName":"ParaGard®","companyName":"FHI 360","companyId":"fhi-360","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ParaGard is a copper-containing intrauterine device (IUD) that prevents pregnancy by creating a toxic environment for sperm and inhibiting fertilization and implantation. Used for Contraception in women of reproductive age.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1984-11-15T00:00:00.000Z","mah":"COOPERSURGICAL","brand_name_local":"PARAGARD T 380A","application_number":"NDA018680"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}