Status:
COMPLETED
Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Grand Challenges Canada
Conditions:
Abortion Early
Eligibility:
FEMALE
18-50 years
Phase:
EARLY_PHASE1
Brief 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 me...
Detailed Description
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 medi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05342974
Start Date
April 19 2022
End Date
January 6 2025
Last Update
March 21 2025
Active Locations (1)
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1
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84102