[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07671989":3,"trial-entities:NCT07671989":124,"trial-summary:NCT07671989":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":13,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":46,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":14,"eligibility_criteria":54,"std_ages":75,"locations":78,"central_contacts":107,"overall_officials":116,"references":119,"see_also_links":120},"NCT07671989","25-45282","Period Pills for Menstrual Regulation: A New Reproductive Health Option","RECRUITING","2027-05-31","2026-06","2026-06-26","2026-06-22","University of California, San Francisco","OTHER",true,"The Period Pills Study is a prospective observational study among people who decide to use a combination of mifepristone and misoprostol for menstrual regulation.","Period pills (a combination of mifepristone and misoprostol) for people who suspect, but have not confirmed pregnancy, has the potential to fulfill this growing need. In the United States (U.S.), a handful of providers currently offer period pills alongside other contraceptive and abortion services in their practice (https:\u002F\u002Fwww.periodpills.org\u002Fproviders). This proposed study would aim to assess the acceptability of this growing service as a fertility regulation method to be utilized before a person confirms they are pregnant.\n\nDr. Ushma Upadhyay (Professor) and Dr. Tania Serna (Associate Clinical Professor) at UCSF's Department of Obstetrics, Gynecology \\& Reproductive Science are proposing the Period Pills Study to test a traditional but underutilized framework of menstrual regulation for pregnancy loss, to \"bring back\" a period when it is late, or missed. This study will aim to recruit 100 participants who have a late period to address research questions that focus on the feasibility and acceptability of using period pills for menstrual regulation.",[18,19],"Menstrual Regulation","Menstrual Health Intervention",[21,22,23],"late period","missed period","mestruation","INTERVENTIONAL",[26],"PHASE4",{"count":28,"type":29},100,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Mifepristone + Misoprostol","Study participants are given mifepristone and misoprostol for menstrual regulation.",[36],"Study Participants",[38,42],{"measure":39,"description":40,"timeFrame":41},"Interest in period pills","The proportion of the clinic-going population that may be interested in a period pill to bring on a late period and accept not having their pregnancy confirmed beforehand, therefore not knowing whether they terminated a pregnancy.","Documented at Enrollment Survey",{"measure":43,"description":44,"timeFrame":45},"Satisfaction with period pills","The proportion of participants reporting being \"satisfied\" or \"very satisfied\" with the period pills on a five-point Likert scale at follow-up (4 weeks).","Documented at Follow-up Survey, 4 weeks after drug administration",[47],{"measure":48,"description":49,"timeFrame":50},"Efficacy of period pills","The proportion of participants that successfully brought down their period, resulting in a negative pregnancy test and the return of their period.","Documented at the follow-up visit, through study completion at around 4 weeks after drug administration.","FEMALE","18 Years",null,{"inclusion":55,"exclusion":65,"raw_text":74},[56,57,58,59,60,61,62,63,64],"Be 18 years old or older","Read and speak English","Know the date of their last menstrual period within 2 days","Have a period that is late by up to 21 days","Must have had regular periods in the last 4 months","Does not want to be pregnant","Does not want to verify pregnancy status","Understand that if they are pregnant, the pills will end their pregnancy","Does not have contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone\u002Fmisoprostol\u002Fprostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)",[66,67,68,69,70,71,72,73],"Under 18 years old","Does not read and speak English","Does not know the date of their last menstrual period within 2 days","Has not had regular periods in the last 4 months","Wants to be pregnant","Wants to verify pregnancy status","Does not display understanding that if they are pregnant, the pills will end their pregnancy","Has any contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone\u002Fmisoprostol\u002Fprostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)","Inclusion Criteria:\n\n* Be 18 years old or older\n* Read and speak English\n* Know the date of their last menstrual period within 2 days\n* Have a period that is late by up to 21 days\n* Must have had regular periods in the last 4 months\n* Does not want to be pregnant\n* Does not want to verify pregnancy status\n* Understand that if they are pregnant, the pills will end their pregnancy\n* Does not have contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone\u002Fmisoprostol\u002Fprostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)\n\nExclusion Criteria:\n\n* Under 18 years old\n* Does not read and speak English\n* Does not know the date of their last menstrual period within 2 days\n* Has not had regular periods in the last 4 months\n* Wants to be pregnant\n* Wants to verify pregnancy status\n* Does not display understanding that if they are pregnant, the pills will end their pregnancy\n* Has any contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone\u002Fmisoprostol\u002Fprostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)",[76,77],"ADULT","OLDER_ADULT",[79,89],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"UCSF Advancing New Standards in Reproductive Health (ANSIRH)","ACTIVE_NOT_RECRUITING","Oakland","California","94612","United States",{"lat":87,"lon":88},37.80437,-122.2708,{"facility":90,"status":7,"city":91,"state":92,"zip":93,"country":85,"contacts":94,"geoPoint":104},"Roanoke Health Center","Roanoke","Virginia","24017",[95,100],{"name":96,"role":97,"phone":98,"email":99},"Christine Hernández, MPH, MPM, CPHQ","CONTACT","828-280-5723","christina.hernandez@ppsat.org",{"name":101,"role":97,"phone":102,"email":103},"Matthew Zerden, MD, MPH","617-935-2394","matthew.zerden@ppsat.org",{"lat":105,"lon":106},37.27097,-79.94143,[108,112],{"name":109,"role":97,"phone":110,"email":111},"Ushma D Upadhyay, PhD, MPH","415-353-4626","ushma.upadhyay@ucsf.edu",{"name":113,"role":97,"phone":114,"email":115},"Jennifer Ko, MLIS","415-353-9113","jennifer.ko@ucsf.edu",[117],{"name":109,"affiliation":12,"role":118},"PRINCIPAL_INVESTIGATOR",[],[121],{"label":122,"url":123},"Period Pills Study Website","https:\u002F\u002Fwww.periodpillstudy.org\u002F",{"nct_id":4,"conditions":125,"biomarkers":126},[19,18],[],{"nct_id":4,"found":14,"summary":128,"prompt_version":138},{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 100 participants.","completed","Period Pills for Menstrual Regulation Study","This study is looking at how acceptable and practical it is for people to use a combination of two medicines, mifepristone and misoprostol, to bring back a late period. This is called menstrual regulation. You might be able to join if you are 18 or older, read English, know your last period date, and your period is up to 21 days late. You also should not want to be pregnant and understand that if you are pregnant, these pills will end the pregnancy. The study wants to enroll 100 participants. Researchers will ask about your interest in using these \"period pills\" and your satisfaction with them after about 4 weeks.","Participants will be followed for 4 weeks after drug administration to assess satisfaction.",110,"You will be given mifepristone and misoprostol. You will complete an enrollment survey and a follow-up survey 4 weeks after taking the medication.","Not stated in the trial record.",[],"v2"]