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Prostaglandin E1 Analog

Atorvastatin + Misoprostol for Pregnancy Termination

Phase < 1

Waitlist Available

Led By David Turok, MD, MPH

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older

Speak English or Spanish

Must not have

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)

Pregnancy over 49 days gestational age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 7 days of initiating atorvastatin (80 mg per day)

Awards & highlights

No Placebo-Only Group

Summary

This trialis testing if a new type of pill can end a pregnancy. Participants take a pill at the clinic, and then take it daily for 6 more days, then return to the clinic and take another pill. Follow-up visits include an ultrasound to check if the abortion was successful.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Atorvastatin may cause muscle pain or weakness (myositis), while misoprostol could lead to cramping or bleeding as it induces uterine contractions to terminate the pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can communicate in English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am more than 7 weeks pregnant.

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I have a history of muscle inflammation.

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I am experiencing vaginal bleeding during my current pregnancy.

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I cannot come back to the clinic for follow-up visits.

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I cannot have a medical abortion due to health reasons.

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I cannot swallow pills.

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I am already taking or plan to take a statin medication during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 7 days of initiating atorvastatin (80 mg per day)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 7 days of initiating atorvastatin (80 mg per day)

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 7 days of initiating atorvastatin (80 mg per day) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Interference in pregnancy progress

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Atorvastatin followed by misoprostolExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atorvastatin

1998

Completed Phase 4

~10900

Misoprostol

2008

Completed Phase 4

~3340