Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy

Completed · Early Phase 1

Conditions studied: Abortion Early

In brief

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.

Key facts

Study ID

NCT05342974

Run by

University of Utah

People needed

9

Starts

2022-04-19

Expected to finish

2025-01-06

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Aged 18 years or older
• A pregnancy confirmed as 35-49 days gestational age through transvaginal ultrasound
• Seeking termination of pregnancy
• Speak English or Spanish
• Willing to potentially delay abortion for 1-2 weeks
• Willing and able to comply with study protocol and accept that the study regimen may not successfully terminate the pregnancy thus a uterine aspiration would be required to complete the abortion.
• Willing to delay contraception until completion of abortion

You may not qualify if…

• People with pregnancy over 49 days gestational age
• Twin or higher multiple pregnancy
• Medical contraindications to medical abortion per the mifepristone U.S. Food and Drug Administration label
• Confirmed or suspected ectopic pregnancy
• Vaginal bleeding in current pregnancy
• Pregnancy of unknown location
• IUD or contraceptive implant in place
• History of allergy to atorvastatin or misoprostol
• History of myositis
• Currently taking or planning on taking medications during the study that interact with HMG co-A reductase inhibitors (e.g., diltiazem, erythromycin, azoles, gemfibrozil or another fibrate)
• Unable to return for clinic-based follow-up
• Currently breastfeeding
• Already taking an HMG co-A reductase inhibitor [37] or plan to take one outside the study drug during the trial (Fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin or rosuvastatin.
• Unable to swallow pills

Where it is running

• Planned Parenthood Association of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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