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Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy
Sponsor: University of Utah
Summary
Medication abortion is a way of ending a pregnancy using pills. The current FDA-approved regimen for medication abortion uses mifepristone and misoprostol. This study is testing whether a different medication, atorvastatin, followed by misoprostol, can be used to end a pregnancy. Participants at 35-49 days of pregnancy will receive an oral dose of atorvastatin (80 mg) to swallow at the clinic as well as taking atorvastatin (80 mg) daily for six additional days, with a return to clinic on day 8 after initial visit to take a dose of misoprostol (800 mcg). Additionally, follow-up visits will occur on approximately days 3, 8 and 11 for a clinician to perform an ultrasound to see if the abortion is complete.
Official title: A Pilot Study of Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2022-04-19
Completion Date
2025-01-06
Last Updated
2026-04-16
Healthy Volunteers
Yes
Conditions
Interventions
Atorvastatin
Oral dose of atorvastatin (80 mg) to swallow at the clinic in the presence of a study provider with additional 6 doses (80 mg each) of atorvastatin to administer at home once daily for the next six days. These 6 pills should be taken orally. Return to the clinic for a follow-up visit approximately 3, 8 and 10 days after enrollment visit. At these visits, trained study clinician will evaluate abortion status using ultrasound and blood draw. At 8-day visit post-enrollment, 800 mcg of misoprostol will be provided to be taken vaginally or allowed to dissolve between cheek and tongue for 30 minutes, within 24 hours of the visit. At the final clinic visit, 10 days post-enrollment, if the termination of pregnancy has failed, standard abortion care at the clinic will be offered. A final phone call to assess any side effects, need for medical care or complications will occur 30 days after enrollment.
Misoprostol
On Study Day 8, participant will be provided will two doses of misoprostol 800 mcg for vaginal or buccal use. Participant will take a single dose of misoprostol on study day 8 (± 1 day), and be instructed to take an additional 800 mcg vaginal or buccal misoprostol if no significant bleeding consistent with passage of tissue (heavier than a menses) has occurred within 24 hours of first misoprostol dose.
Locations (1)
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States