Abortion EarlyEarly Phase 1NCT05342974
Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy
A Early Phase 1 study testing Atorvastatin and Misoprostol in people with Abortion Early, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Early
- What is being tested?
- Atorvastatin and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 6 Jan 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 years or older
- A pregnancy confirmed as 35-49 days gestational age through transvaginal ultrasound
- Seeking termination of pregnancy
- Speak English or Spanish
- Willing to potentially delay abortion for 1-2 weeks
- Willing and able to comply with study protocol and accept that the study regimen may not successfully terminate the pregnancy thus a uterine aspiration would be required to complete the abortion.
- Willing to delay contraception until completion of abortion
Who cannot join
- People with pregnancy over 49 days gestational age
- Twin or higher multiple pregnancy
- Medical contraindications to medical abortion per the mifepristone U.S. Food and Drug Administration label
- Confirmed or suspected ectopic pregnancy
- Vaginal bleeding in current pregnancy
- Pregnancy of unknown location
Show all 14Show fewer
- IUD or contraceptive implant in place
- History of allergy to atorvastatin or misoprostol
- History of myositis
- 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)
- Unable to return for clinic-based follow-up
- Currently breastfeeding
- Already taking an HMG co-A reductase inhibitor [37] or plan to take one outside the study drug during the trial (Fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin or rosuvastatin.
- Unable to swallow pills
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102
About this study
Official title: A Pilot Study of Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy
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.
Read the detailed 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.
- Conditions
- Abortion Early
- Being tested
- Atorvastatin, Misoprostol
- Keywords
- abortion, medical abortion, atorvastatin, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
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.
MisoprostolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Atorvastatin followed by misoprostol | Experimental | 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. Receives: Drug: Atorvastatin; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interference in pregnancy progress
This is a dichotomous outcome that includes interference in pregnancy progress by any of the following: 1) ultrasound markers as measured by transvaginal ultrasonographic loss of embryonic cardiac activity if previously documented, or 2) abnormal ultrasonographic growth over seven day period consistent with the "Diagnostic Criteria for Nonviable Pregnancy Early in the First Trimester" (this includes "findings suspicious for, but not diagnostic of, pregnancy failure" which encompass no visualization of an embryo seven days after a gestational sac is seen, N Engl J Med 2013;369:1443-51.), 3) any decrease in human chorionic gonadotrophin measures, or 4) an insufficient rise in quantitative HCG if baseline HCG is ≤5000 including: a decrease or increase of less than 50% in quantitative HCG from day 1 to 3; a decrease or increase of less than 100% in quantitative HCG from day 3 to 8, or 5) passage of the pregnancy confirmed by ultrasound prior to misoprostol use.
Measured: Within 7 days of initiating atorvastatin (80 mg per day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start19 Apr 2022
- Primary completion31 Dec 2023
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada
- Responsible party
- Sponsor
- Investigators
- David Turok, MD, MPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342974
- Sponsor's protocol ID
- 00148011
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD may be shared with other researchers with a legitimate and proven interest in conducting further analyses.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy
- ClinicalTrials.gov ID
- NCT05342974
- Acronym / sponsor ID
- 00148011
- Conditions
- Abortion Early
- Keywords
- abortion, medical abortion, atorvastatin, misoprostol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Grand Challenges Canada
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Atorvastatin followed by misoprostol | Experimental | Drug: Atorvastatin, Drug: MisoprostolOral 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- A pregnancy confirmed as 35-49 days gestational age through transvaginal ultrasound
- Seeking termination of pregnancy
- Speak English or Spanish
- Willing to potentially delay abortion for 1-2 weeks
Key exclusion criteria (14 listed)
- People with pregnancy over 49 days gestational age
- Twin or higher multiple pregnancy
- Medical contraindications to medical abortion per the mifepristone U.S. Food and Drug Administration label
- Confirmed or suspected ectopic pregnancy
- Vaginal bleeding in current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinOral 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 | Experimental: Atorvastatin followed by misoprostol |
| MisoprostolOn 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. | Drug | Experimental: Atorvastatin followed by misoprostol |
Primary outcome
Interference in pregnancy progress
Time frame: Within 7 days of initiating atorvastatin (80 mg per day)
This is a dichotomous outcome that includes interference in pregnancy progress by any of the following: 1) ultrasound markers as measured by transvaginal ultrasonographic loss of embryonic cardiac activity if previously documented, or 2) abnormal ultrasonographic growth over seven day period consistent with the "Diagnostic Criteria for Nonviable Pregnancy Early in the First Trimester" (this includes "findings suspicious for, but not diagnostic of, pregnancy failure" which encompass no visualization of an embryo seven days after a gestational sac is seen, N Engl J Med 2013;369:1443-51.), 3) any decrease in human chorionic gonadotrophin measures, or 4) an insufficient rise in quantitative HCG if baseline HCG is ≤5000 including: a decrease or increase of less than 50% in quantitative HCG from day 1 to 3; a decrease or increase of less than 100% in quantitative HCG from day 3 to 8, or 5) passage of the pregnancy confirmed by ultrasound prior to misoprostol use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD may be shared with other researchers with a legitimate and proven interest in conducting further analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Turok, MD, MPH principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Atorvastatin and Misoprostol in people with Abortion Early, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interference in pregnancy progress (time frame: Within 7 days of initiating atorvastatin (80 mg per day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.