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Missed AbortionPhase 2NCT05216952

Ulipristal Acetate for Use in Early Pregnancy Loss

A Phase 2 study testing Ulipristal Acetate Tablets and Misoprostol Pill in people with Missed Abortion and Anembryonic Pregnancy, run by University of North Carolina, Chapel Hill at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators will study the feasibility of using 90mg ulipristal acetate, a selective progesterone receptor agonist, as an adjunct to 800mcg vaginal misoprostol for the medical management of early pregnancy loss. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Ulipristal Acetate Tablets and Misoprostol Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
4 sitesUnited States
Study dates
11 May 2022to 30 Apr 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, age 18 years or older
  • English- or Spanish-speaking
  • Ultrasound examination showing a non-viable intrauterine pregnancy between 5- and 12-weeks' gestation or anembryonic gestation
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Provision of signed and dated informed consent form

Who cannot join

  • Desire for non-medical management of early pregnancy loss (either expectant management or surgical management)
  • Hemodynamically unstable
  • Evidence of incomplete or inevitable abortion (due to high efficacy of misoprostol alone)
  • Contraindication or allergy to ulipristal acetate or misoprostol (glaucoma, mitral stenosis, sickle cell anemia, chronic glucocorticoid use)
  • Evidence of a viable intrauterine pregnancy, ectopic pregnancy, or pregnancy with intrauterine device in place
  • Evidence of pelvic infection
Show all 19Show fewer
  • Hemoglobin <9.5g/dL
  • Known cardiovascular disease (arrhythmia, cardiac failure, valvular disease, angina)
  • Known clotting or bleeding disorder, or on anticoagulation therapy
  • Use of the following medications that may influence metabolization of the study medications: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate
  • Use of CYP3A4 inhibitors within five elimination half-lives of ulipristal acetate or other strong CYP3A4 inhibitors
  • Chronic adrenal failure (risk of acute renal insufficiency)
  • Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
  • Any history of underlying liver disorder, including hepatitis
  • Elevation of any or all liver enzymes (alanine aminotransferase, aspartate aminotransferase, total bilirubin) above the upper limit of normal (ULN) at baseline testing prior to enrollment
  • A family history of hepatitis or currently living with a person who has been given a diagnosis of hepatitis
  • A history of or currently working as a sex worker
  • A history of or currently using intravenous (IV) drugs
  • A self-reported history of alcohol dependency or abuse

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of North Carolina, Chapel Hill - Same Day OBGYN Clinic

    Chapel Hill, North Carolina, 27514

  • University of North Carolina, Chapel Hill - Vilcom Center

    Chapel Hill, North Carolina, 27514

  • University of North Carolina, Chapel Hill - Weaver Crossing

    Chapel Hill, North Carolina, 27514

  • University of North Carolina, Chapel Hill - Hillsborough Medical Office Building

    Hillsborough, North Carolina, 27278

Other trials in United States

About this study

Official title: Ulipristal Acetate for Use in Early Pregnancy Loss: A Phase 2 Pilot Feasibility Study

The investigators will study the feasibility of using 90mg ulipristal acetate, a selective progesterone receptor agonist, as an adjunct to 800mcg vaginal misoprostol for the medical management of early pregnancy loss. Patients will be followed to assess effective treatment of early pregnancy loss, additional interventions needed, side effects, adverse events and patient acceptability.

Read the detailed description

Study Background: Early pregnancy loss affects approximately 10% of women throughout their reproductive lives and many women desire medical management of early pregnancy loss. Data from two large randomized controlled trials suggests that pretreatment with mifepristone 200mg, a selective progesterone receptor modulator, prior to administration of misoprostol 800mcg increases effectiveness of medical management of early pregnancy loss and decreases the need for subsequent surgical management. Ulipristal acetate (UPA) is another selective progesterone receptor modulator that may allow for similar priming of the cervix and sensitization of the myometrium to the prostaglandins to improve effectiveness of misoprostol in medical management of early pregnancy loss. Ulipristal acetate is available as a prescription medication through commercial pharmacies. Thus, utilizing UPA plus misoprostol for early pregnancy loss may improve access to patients.

Study Objectives:

Primary Objective:

  • To assess if 90mg ulipristal acetate as an adjunct to 800mcg vaginal misoprostol is a feasible method for medical management of early pregnancy loss.

Secondary Objectives:

  • To evaluate if participants taking ulipristal acetate plus misoprostol achieve complete resolution of early pregnancy loss.
  • To investigate if patients using ulipristal acetate plus misoprostol have side effects or adverse events when used for early pregnancy loss.
  • To identify if patients find ulipristal acetate and misoprostol an acceptable treatment for early pregnancy loss.

Study Population: Participants eligible for the study include women over age 18 presenting with a non-viable pregnancy between 5- and 12-weeks gestation or an anembryonic gestation and desiring medical management.

Study Location: All study activities will take place at University of North Carolina-Chapel Hill (UNC). Participants will be recruited from OBGYN clinics following diagnosis of early pregnancy loss on viability scan. All follow up study activities will take place at UNC Chapel Hill Family Planning Clinic.

Study Intervention: Ulipristal acetate is a selective progesterone receptor modulator that is currently FDA approved for the use of emergency contraception. Three 30mg tablets will be administered orally for a total dose of 90mg. Participants will be instructed to self-administer 800mcg of misoprostol 6 to 18 hours after receiving ulipristal acetate as per the standard of care for early pregnancy loss management. Participants will be followed for resolution of their early pregnancy loss.

Being tested
Ulipristal Acetate Tablets, Misoprostol Pill
Keywords
Medical management of miscarriage
Medical subject headings
Abortion, Missed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ulipristal Acetate TabletsDrug

    Also called Ella

    90mg (three 30mg tablets) administered orally once

  • Misoprostol PillDrug

    Also called Cytotec

    800mcg (four 200mcg pills) administered vaginally once 6-18 hours following ulipristal acetate

Study groups in NCT05216952
Study groupRoleWhat they receive
UPA 90mgExperimentalParticipants receive ulipristal acetate 90mg PO followed by self-administration of misoprostol 800mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Receives: Drug: Ulipristal Acetate Tablets; Drug: Misoprostol Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Recruited to Study Protocol

    Measured as number of participants enrolled in study divided by number of patients screened for participation in study

    Measured: Baseline

  2. Percentage of Participants Adherent to Study Protocol

    Measured as number of participants self reporting adherence to study intervention of ulipristal acetate followed by misoprostol taken 6-18 hours later divided by number of participants enrolled in study.

    Measured: From admission until day 3 follow up, +/- 1 day

  3. Percentage of Participants Retained in Study Protocol

    Measured as number of participants attending all required study visits (day 0, day 3, day 8, and day 30) divided by number of participants enrolled in study

    Measured: From admission until day 30 follow up, +/- 7 days

Secondary outcomes (4)

  1. Number of Participants With Resolution of Early Pregnancy Loss Following Study Intervention

    Absence of gestational sac on transvaginal ultrasound examination on day 3 follow up

    Measured: From admission until day 3 follow up, +/- 1 day

  2. Number of Participants With Treatment-Related Side Effects

    Participant reported side effects based on pre-specified list of common side effects (fatigue, headache, dizziness, chills, nausea, diarrhea, vomiting, severe cramping, and fever) that may occur with medication management of early pregnancy loss.

    Measured: From admission until day 30 follow up, +/- 7 days

  3. Number of Participants With Treatment-Related Adverse Events

    Participant reported adverse events based on pre-specified list (bleeding requiring hospitalization and/or blood transfusion, pelvic infection requiring hospitalization and/or antibiotics) that may occur with medication management of early pregnancy loss.

    Measured: From admission until day 30 follow up, +/- 7 days

  4. Median Acceptability of Study Intervention

    Participant reported ordinal data based on 4 Likert scale questions about acceptability of study intervention with scores ranging from 1-5 (1=Very Unlikely, 2=More Unlikely, 3=Neutral, 4=More Likely, 5=Very Likely). Higher scores indicated more acceptable treatment.

    Measured: From admission until day 30 follow up, +/- 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start11 May 2022
  3. Primary completion3 Jan 2023
  4. Study completion30 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216952
Sponsor's protocol ID
21-2315
Other IDs
C21-1493
Status last verified
Jun 2023
First submitted
19 Jan 2022
Last updated
28 Jun 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

  • Hagey JM, Tang JH, Morse JE, Bryant AG. Ulipristal acetate for use in medical management of early pregnancy loss: a pilot feasibility study. BMC Pregnancy Childbirth. 2026 Jul 2. doi: 10.1186/s12884-026-09485-4. Online ahead of print.

    PubMed 42387351

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ulipristal Acetate Tablets and Misoprostol Pill in people with Missed Abortion and Anembryonic Pregnancy, run by University of North Carolina, Chapel Hill at 4 sites 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 5 inclusion and 19 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Recruited to Study Protocol (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05216952, which also lists 1 linked publication.

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 28 Jun 2023.

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