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

9 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Turok, MD, MPH

Principal Investigator

University of Utah

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+