Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy

Abortion Early Clinical Trial

Official title: A Pilot Study of Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 medication abortion. Finding another medication that replace mifepristone would benefit both those who need abortions and providers around the world. Atorvastatin might be one drug that could do this. It is a statin that is commercially available in many countries.

Goal: To evaluate the safety and effectiveness of a user-friendly atorvastatin-misoprostol regimen

Primary Objective: Successful interference in pregnancy progress, decreases in measurable human chorionic gonadotrophin (HCG) hormone, or an end of pregnancy (prior to misoprostol use) within seven days of starting atorvastatin (80 mg per day for seven days).

Sample Size: 30 patients

Location: Recruitment of all participants and data collection will take place at Planned Parenthood Association of Utah.

Study Population: People presenting to the study site for medical abortion who have an intrauterine pregnancy visible on ultrasound with a single fetus ≤ 49 days gestational age.

Study Procedures:

STUDY DAY 1 (at clinic) The pregnancy will be confirmed to be 35- 49 days gestational age through transvaginal ultrasound. Baseline data will be collected including pregnancy symptoms and prior medical pregnancy history. Atorvastatin will be started at 80 mg per day for 7 days (first dose taken in clinic). The remaining six doses will be provided to take at home. A blood draw will occur to measure HCG hormone levels.

STUDY DAY 3 (at clinic) Participants will come to clinic, and blood will be drawn to measure HCG hormone levels and a transvaginal ultrasound will occur to monitor pregnancy status.

STUDY DAY 8 (at clinic, day after final day of atorvastatin) A transvaginal ultrasound will be completed to view pregnancy status. Participant will be provided two doses of misoprostol (800 mcg) that can be taken buccally (inserted into cheeks until they dissolve - approximately 30 minutes) or inserted vaginally. The second dose will be taken at home if participant does not experience bleeding that indicates end of pregnancy (heavier than a standard period) within 24 hours.

STUDY DAY 9-11 FOLLOW-UP (at clinic):

In clinic, an exam will be conducted to confirm that the abortion has been completed and to review symptoms that have occurred. If the abortion is not complete, a standard abortion with uterine evacuation will be provided within the week to complete the abortion.

EXTENDED FOLLOW-UP (by text, email, or phone):

30 days after starting the study, participants will be contacted to document any side effects or any needed medical care related to the abortion or complications from the abortion. This will occur through phone or email. These follow up data will address any lasting side effects, need for additional medical care, and complications. ;

Related Conditions & MeSH terms

• Abortion Early

• NCT number: NCT05342974
• Study type: Interventional
• Source: University of Utah
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: April 19, 2022
• Completion date: December 31, 2024