Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy

NCT05342974 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 00148011
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Abortion Early

Keywords

abortion; medical abortion; atorvastatin; misoprostol

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 7 days of initiating atorvastatin (80 mg per day)

Study Arms (1)

Experimental: Atorvastatin followed by misoprostol

EXPERIMENTAL

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

Interventions

Atorvastatin DRUG

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.

Experimental: Atorvastatin followed by misoprostol

Misoprostol DRUG

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.

Experimental: Atorvastatin followed by misoprostol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Utah: lead
• Grand Challenges Canada: collaborator

Study Sites (1)

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

Location

MeSH Terms

Interventions

Atorvastatin; Misoprostol

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• David Turok, MD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 25, 2022
• Study Start: April 19, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 6, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 5 years from completion of study
• Access Criteria: Requests made to the PI via email will be considered.

Locations

US (1)