A Phase 4 interventional study of Mifepristone + 2 doses of misoprostol 800 mcg in Medical Abortion, sponsored by Gynuity Health Projects. Terminated at 6 sites in United States. Open to female participants aged 11 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Gynuity Health Projects · Phase 4, Interventional, and Treatment
This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.
Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Pregnant people whose pregnancies are estimated to have a gestational age of 71-77 days. (Participants in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range).
Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days.
Drug: Mifepristone + 2 doses of misoprostol 800 mcg
Will use a mifepristone-misoprostol regimen of: 200 mg mifepristone followed in 24-48 hours by a first dose of 800 µg misoprostol buccally and then in another 4 hours by a second dose of 800 µg misoprostol buccally. For buccal administration of misoprostol, participants will place 2 misoprostol tablets in each cheek and hold them for 20-30 minutes, after which they will swallow any remnants.
Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason
Proportion of women who achieve complete abortion with medication only and without aspiration or D\&E
Time frame: 7-36 days after initial visit
Proportion of participants who report each individual side effect
Side effects include diarrhea, nausea, vomiting, fever, chills
Time frame: 7-14 days after initial visit
Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization
Complications could include abnormal bleeding, severe pain, retained tissue
Time frame: 7-14 days after initial visit
Proportion of participants who determine method acceptable
Overall acceptability, time to complete abortion, bleeding, side effects, pain
Time frame: 7-36 days after initial visit
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects