Atorvastatin + Misoprostol for Pregnancy Termination

Overseen By David Turok, MD, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Utah

Must not be taking: HMG co-A reductase inhibitors

Disqualifiers: Pregnancy over 49 days, twins, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 8 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether atorvastatin, a cholesterol-lowering drug, followed by misoprostol (Cytotec), can safely end a pregnancy. Researchers aim to determine if this combination serves as an alternative to the current FDA-approved method. Women who are 35-49 days pregnant and interested in terminating their pregnancy may qualify for this trial. Participants must be comfortable taking pills over several days and attending follow-up visits. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking medical research.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications that interact with atorvastatin, such as diltiazem, erythromycin, azoles, and gemfibrozil. If you are already taking any HMG co-A reductase inhibitors (a type of cholesterol-lowering drug), you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that using atorvastatin during pregnancy requires careful consideration. A study of 2,447 women who took statins, such as atorvastatin, while pregnant did not find a significant increase in harmful outcomes compared to those who didn’t take these drugs. However, atorvastatin is usually not recommended during pregnancy due to possible risks.

Misoprostol, in contrast, is a common medication used to end pregnancies. It is part of the standard medical abortion process and is generally well-tolerated. Serious side effects with misoprostol are rare, occurring in only about 0.16% of cases.

This trial tests the combination of atorvastatin followed by misoprostol. While the safety of atorvastatin in this specific use is still under study, current data suggests that close monitoring is important. Participants should discuss potential risks and benefits with their healthcare providers before joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for pregnancy termination typically rely on a combination of mifepristone and misoprostol. However, researchers are excited about the potential of using atorvastatin combined with misoprostol. Atorvastatin is traditionally used to lower cholesterol but, in this context, it may enhance the effectiveness of misoprostol by preparing the body more efficiently for the drug's action. This approach could potentially improve the success rate of the procedure and reduce the need for additional doses, offering a new mechanism of action compared to the current standard treatments.

What evidence suggests that atorvastatin followed by misoprostol could be effective for pregnancy termination?

Research has shown that using misoprostol alone effectively induces abortions, with studies indicating it safely leads to a complete abortion most of the time. In nearly 13,000 cases, misoprostol proved effective and safe for first-trimester abortions. In this trial, participants will receive atorvastatin followed by misoprostol. Although researchers are testing atorvastatin as a new addition to this process, no solid evidence currently exists on its effectiveness in ending pregnancies. The hypothesis is that atorvastatin might enhance the effects of misoprostol, but this remains under study. ^{2 6 7 8 9}

Who Is on the Research Team?

David Turok, MD, MPH

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are up to 49 days pregnant and want an abortion. They must speak English or Spanish, be able to follow the study plan, and agree to possibly delay their abortion by 1-2 weeks. People can't join if they're over this pregnancy stage, have certain medical conditions, use conflicting drugs, can't return for follow-ups, are breastfeeding or already on similar medications.

Inclusion Criteria

Seeking termination of pregnancy

Willing to delay contraception until completion of abortion

Willing to potentially delay abortion for 1-2 weeks

Exclusion Criteria

I am taking or will take medications that interact with cholesterol drugs.

IUD or contraceptive implant in place

Twin or higher multiple pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive atorvastatin (80 mg) daily for 7 days, followed by misoprostol (800 mcg) on day 8

8 days

3 visits (in-person)

Follow-up

Participants are monitored for completion of abortion and any symptoms, with a potential uterine evacuation if necessary

3 days

1 visit (in-person)

Extended Follow-up

Participants are contacted to document any side effects or needed medical care related to the abortion or complications

30 days

Remote follow-up (text, email, or phone)

What Are the Treatments Tested in This Trial?

Interventions

• Atorvastatin
• Misoprostol

Trial Overview The study tests if atorvastatin followed by misoprostol can end a pregnancy. Participants will take atorvastatin orally for seven days and then misoprostol on the eighth day in the clinic. Their progress will be monitored through ultrasounds on approximately days 3, 8 and 11.

How Is the Trial Designed?

Group I: Experimental: Atorvastatin followed by misoprostol Experimental Treatment 2 Interventions

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.

Misoprostol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cytotec for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Approved in European Union as Misoprostol for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Approved in Canada as Misoprostol for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Grand Challenges Canada

Collaborator

Trials

63

Recruited

95,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6309472/

Efficacy of Misoprostol Alone for First-Trimester Medical ... Data from 42 studies that included nearly 13,000 evaluable women indicate that misoprostol used alone can be effective and safe for inducing abortion in the ...

2. jsurgmed.com jsurgmed.com/article/view/7713

Misoprostol and pregnancy terminations Conclusion: Our results indicated that misoprostol is a safe, useful, and effective treatment option for second trimester medical terminations.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05342974/atorvastatin-as-a-potential-adjunct-to-misoprostol-for-termination-of-pregnancy

Atorvastatin as a Potential Adjunct to Misoprostol for ... This study is testing whether a different medication, atorvastatin, followed by misoprostol, can be used to end a pregnancy.

4. withpower.com withpower.com/trial/early-phase-1-early-abortion-3-2022-8cdc2

Atorvastatin + Misoprostol for Pregnancy Termination Trial Overview The study tests if atorvastatin followed by misoprostol can end a pregnancy. Participants will take atorvastatin orally for seven days and then ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37390948/

Clinical outcomes of medication abortion using misoprostol ... Medication abortion with misoprostol-only was safe and produced complete abortion in most patients with follow-up.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3711556/

Significant Adverse Events and Outcomes After Medical Abortion The most common significant outcome was ongoing intrauterine pregnancy (0.50%); significant adverse events occurred in 0.16% of cases. One patient death ...

7. cdek.liu.edu cdek.liu.edu/trial/NCT05342974/

Trial | NCT05342974 Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy ... safety and effectiveness of a user-friendly atorvastatin-misoprostol regimen

8. turkjpediatr.org turkjpediatr.org/article/download/856/855/855

Birth outcomes after inadvertent use of category X drugs ... We collected data about complications during pregnancy and details of the outcomes (live birth, preterm birth, birth defect, stillbirth, miscarriage, elective ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9558136/

The effect of statins exposure during pregnancy on congenital ... Pregnancy outcomes of 2,447 women that received statins during pregnancy were compared to 897,280 pregnant women who did not. Treatment with ...