Phase 2
N=3
Ulipristal Acetate for Use in Early Pregnancy Loss
Missed Abortion · Anembryonic Pregnancy · Non-Viable Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT05216952 ↗Enrolled (actual)
3
Serious AEs
33.3%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Participants Recruited to Study Protocol — 37.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ulipristal Acetate Tablets (Drug); Misoprostol Pill (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Recruited to Study Protocol |
37.5 | — |
| PRIMARY Percentage of Participants Adherent to Study Protocol |
100 | — |
| PRIMARY Percentage of Participants Retained in Study Protocol |
100 | — |
| SECONDARY Number of Participants With Resolution of Early Pregnancy Loss Following Study Intervention |
3 | — |
| SECONDARY Number of Participants With Treatment-Related Side Effects |
2; 0; 2; 1; 1; 0 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events |
1; 0; 0 | — |
| SECONDARY Median Acceptability of Study Intervention |
3; 4; 4; 3 | — |
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. Patients will be followed to assess effective treatment of early pregnancy loss, additional interventions needed, side effects, adverse events and patient acceptability.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT05216952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.