Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

April 19, 2022

Primary Completion Date

December 31, 2023

Study Completion Date

January 6, 2025

Conditions
Abortion Early
Interventions
DRUG

Atorvastatin

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.

DRUG

Misoprostol

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.

Trial Locations (1)

84102

Planned Parenthood Association of Utah, Salt Lake City

All Listed Sponsors
collaborator

Grand Challenges Canada

OTHER

lead

University of Utah

OTHER