Ulipristal Acetate for Use in Early Pregnancy Loss

NCT05216952 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 21-2315C21-1493
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Missed Abortion; Anembryonic Pregnancy; Non-Viable Pregnancy

Keywords

Medical management of miscarriage

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline

• 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.

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

• 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

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

Secondary Outcomes (4)

• Number of Participants With Resolution of Early Pregnancy Loss Following Study Intervention

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

• Number of Participants With Treatment-Related Side Effects

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

• Number of Participants With Treatment-Related Adverse Events

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

• Median Acceptability of Study Intervention

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

Other Outcomes (2)

• Number of Participants Needing Additional Medication for Resolution of Early Pregnancy Loss

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

• Number of Participants Needing Surgical Management for Resolution of Early Pregnancy Loss

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

Study Arms (1)

UPA 90mg

EXPERIMENTAL

Participants receive ulipristal acetate 90mg PO followed by self-administration of misoprostol 800mcg vaginally 6 to 18 hours following ulipristal acetate administration.

Drug: Ulipristal Acetate Tablets; Drug: Misoprostol Pill

Interventions

Ulipristal Acetate Tablets DRUG

90mg (three 30mg tablets) administered orally once

Also known as: Ella

UPA 90mg

Misoprostol Pill DRUG

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

Also known as: Cytotec

UPA 90mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (4)

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

Chapel Hill, North Carolina, 27514, United States

Location

University of North Carolina, Chapel Hill - Vilcom Center

Chapel Hill, North Carolina, 27514, United States

Location

University of North Carolina, Chapel Hill - Weaver Crossing

Chapel Hill, North Carolina, 27514, United States

Location

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

Hillsborough, North Carolina, 27278, United States

Location

MeSH Terms

Conditions

Abortion, Missed

Interventions

ulipristal acetate; Misoprostol

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Jill Hagey, MD, MPH
• Organization: University of North Carolina at Chapel Hill

jmhagey1@ad.unc.edu

919-966-5280

Study Officials

• Jill M Hagey, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: May 11, 2022
• Primary Completion: January 3, 2023
• Study Completion: April 30, 2023
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study protocol, statistical analysis plan and informed consent form will be shared beginning 9 to 36 months following publication of results.
• Access Criteria: Following approval from an appropriate review board as described above and execution of a data use/sharing agreement with UNC-Chapel Hill.

Locations

US (4)