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

21-2315

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.

2022-05-11

2023-01-03

2023-04-30

Completed

Early phase I

3

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3, 'type': 'ACTUAL'}}

2023-06-28