An Early Phase 1 interventional study of Atorvastatin and Misoprostol in Abortion Early, sponsored by University of Utah. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by University of Utah · Early Phase 1, Interventional, and Other
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.
Safe and legal abortion is an important part of reproductive health. Medication abortion using a combination of mifepristone and misoprostol is recognized worldwide as the gold standard for early medication abortion. Finding another medication that replace mifepristone would benefit both those who need abortions and providers around the world. Atorvastatin might be one drug that could do this. It is a statin that is commercially available in many countries.
Goal: To evaluate the safety and effectiveness of a user-friendly atorvastatin-misoprostol regimen
Primary Objective: Successful interference in pregnancy progress, decreases in measurable human chorionic gonadotrophin (HCG) hormone, or an end of pregnancy (prior to misoprostol use) within seven days of starting atorvastatin (80 mg per day for seven days).
Sample Size: 30 patients
Location: Recruitment of all participants and data collection will take place at Planned Parenthood Association of Utah.
Study Population: People presenting to the study site for medical abortion who have an intrauterine pregnancy visible on ultrasound with a single fetus ≤ 49 days gestational age.
Study Procedures:
STUDY DAY 1 (at clinic) The pregnancy will be confirmed to be 35- 49 days gestational age through transvaginal ultrasound. Baseline data will be collected including pregnancy symptoms and prior medical pregnancy history. Atorvastatin will be started at 80 mg per day for 7 days (first dose taken in clinic). The remaining six doses will be provided to take at home. A blood draw will occur to measure HCG hormone levels.
STUDY DAY 3 (at clinic) Participants will come to clinic, and blood will be drawn to measure HCG hormone levels and a transvaginal ultrasound will occur to monitor pregnancy status.
STUDY DAY 8 (at clinic, day after final day of atorvastatin) A transvaginal ultrasound will be completed to view pregnancy status. Participant will be provided two doses of misoprostol (800 mcg) that can be taken buccally (inserted into cheeks until they dissolve - approximately 30 minutes) or inserted vaginally. The second dose will be taken at home if participant does not experience bleeding that indicates end of pregnancy (heavier than a standard period) within 24 hours.
STUDY DAY 9-11 FOLLOW-UP (at clinic):
In clinic, an exam will be conducted to confirm that the abortion has been completed and to review symptoms that have occurred. If the abortion is not complete, a standard abortion with uterine evacuation will be provided within the week to complete the abortion.
EXTENDED FOLLOW-UP (by text, email, or phone):
30 days after starting the study, participants will be contacted to document any side effects or any needed medical care related to the abortion or complications from the abortion. This will occur through phone or email. These follow up data will address any lasting side effects, need for additional medical care, and complications.
University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
Oral dose of atorvastatin (80 mg) to be taken daily for seven days followed by misoprostol (800 mcg) on day 8. A second dose of misoprostol will occur 24 hours after the first dose if no significant bleeding (more than a regular period) has occurred.
Drug: Atorvastatin · Drug: Misoprostol
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.
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.
Interference in pregnancy progress
This is a dichotomous outcome that includes interference in pregnancy progress by any of the following: 1) ultrasound markers as measured by transvaginal ultrasonographic loss of embryonic cardiac activity if previously documented, or 2) abnormal ultrasonographic growth over seven day period consistent with the "Diagnostic Criteria for Nonviable Pregnancy Early in the First Trimester" (this includes "findings suspicious for, but not diagnostic of, pregnancy failure" which encompass no visualization of an embryo seven days after a gestational sac is seen, N Engl J Med 2013;369:1443-51.), 3) any decrease in human chorionic gonadotrophin measures, or 4) an insufficient rise in quantitative HCG if baseline HCG is ≤5000 including: a decrease or increase of less than 50% in quantitative HCG from day 1 to 3; a decrease or increase of less than 100% in quantitative HCG from day 3 to 8, or 5) passage of the pregnancy confirmed by ultrasound prior to misoprostol use.
Time frame: Within 7 days of initiating atorvastatin (80 mg per day)
Plan to share: Yes — De-identified IPD may be shared with other researchers with a legitimate and proven interest in conducting further analyses.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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