Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Collaborator: Grand Challenges Canada
• Treatments: Atorvastatin; Misoprostol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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