NCT05216952 is a Phase 2 clinical trial of Ulipristal Acetate Tablets in Missed Abortion, sponsored by University of North Carolina, Chapel Hill.

Who is sponsoring NCT05216952?

NCT05216952 is sponsored by University of North Carolina, Chapel Hill.

What drugs are being tested in NCT05216952?

Interventions in NCT05216952: Ulipristal Acetate Tablets, Misoprostol Pill.

What condition does NCT05216952 study?

NCT05216952 studies Missed Abortion, Anembryonic Pregnancy, Non-Viable Pregnancy.

Is NCT05216952 still recruiting?

NCT05216952 is currently completed. Last updated 28 June 2023.

Are results published for NCT05216952?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-06-28 · How we verify

NCT05216952

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ulipristal Acetate for Use in Early Pregnancy Loss

Completed Phase 2 Results posted Last updated 28 June 2023

What this trial tests

Phase 2 trial testing Ulipristal Acetate Tablets in Missed Abortion in 3 participants. Completed in 30 April 2023.

Timeline

11 May 2022

Primary endpoint
3 January 2023

30 April 2023

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	11 May 2022
Primary completion	3 January 2023
Estimated completion	30 April 2023
Sites	4 locations across United States

Drugs / interventions tested

Ulipristal Acetate Tablets — full drug profile →
Misoprostol Pill — full drug profile →

Conditions studied

Missed Abortion — all drugs for Missed Abortion →
Anembryonic Pregnancy — all drugs for Anembryonic Pregnancy →
Non-Viable Pregnancy — all drugs for Non-Viable Pregnancy →

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, female only, with Missed Abortion or Anembryonic Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Recruited to Study Protocol Primary · Baseline

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

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	37.5

Percentage of Participants Adherent to Study Protocol Primary · From admission until day 3 follow up, +/- 1 day

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.

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	100

Percentage of Participants Retained in Study Protocol Primary · From admission until day 30 follow up, +/- 7 days

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

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	100

Number of Participants With Resolution of Early Pregnancy Loss Following Study Intervention Secondary · From admission until day 3 follow up, +/- 1 day

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

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	3

Number of Participants With Treatment-Related Side Effects Secondary · From admission until day 30 follow up, +/- 7 days

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.

Fatigue

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	2

Headache

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	0

Dizziness

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	2

Chills

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	1

Nausea

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	1

Diarrhea

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	0

Vomiting

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	0

Severe cramping

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	1

Number of Participants With Treatment-Related Adverse Events Secondary · From admission until day 30 follow up, +/- 7 days

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.

Bleeding requiring hospitalization and/or blood transfusion

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	1

Pelvic infection requiring hospitalization and/or antibiotics

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	0

Other

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	0

Median Acceptability of Study Intervention Secondary · From admission until day 30 follow up, +/- 7 days

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.

Would you use these medications again if you had another miscarriage?

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	3	1 – 5

Would you recommend these medications to a friend with a miscarriage?

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	4	3 – 5

If possible to take Ulipristal Acetate (UPA) at home, would you be more or less likely to use again?

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	4	3 – 4

If possible to take UPA at a different time, would you be more or less likely to use again?

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	3	3 – 4

Number of Participants Needing Additional Medication for Resolution of Early Pregnancy Loss Secondary · From admission until day 30 follow up, +/- 7 days

Participant reported need for additional dose of misoprostol for resolution of early pregnancy loss.

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	0

Number of Participants Needing Surgical Management for Resolution of Early Pregnancy Loss Secondary · From admission until day 30 follow up, +/- 7 days

Participant reported need for vacuum aspiration for resolution of early pregnancy loss.

Group	Value	95% CI
Ulipristal Acetate (UPA) 90 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of signing informed consent through study completion, 30 days +/- 7 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ulipristal Acetate (UPA) 90 mg

Serious: 1/3 (33%)

Deaths: 0/3

Serious adverse events (1 terms)

Reaction	System	Ulipristal Acetate (UPA) 9…
Vaginal Bleeding Requiring Hospitalization	Pregnancy, puerperium and perinatal conditions	—

Other adverse events (5 terms — click to expand)

Reaction	System	Ulipristal Acetate (UPA) 9…
Fatigue	General disorders	—
Dizziness	General disorders	—
Chills	Infections and infestations	—
Severe cramping	Reproductive system and breast disorders	—
Nausea	Gastrointestinal disorders	—

Most-reported serious reactions: Vaginal Bleeding Requiring Hospitalization.

Data from ClinicalTrials.gov NCT05216952 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Missed Abortion

Currently open trials in the same condition.

NCT07422506 — A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion · NA · recruiting
NCT05516810 — The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles · active not recruiting

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

NCT06841913 — Woodsmoke Exposure, Influenza Infection, and Nasal Immunity · Phase 4 · suspended
NCT07383428 — The INICIO-Guatemala Study · NA · not yet recruiting
NCT07528443 — Ultraprocessed Foods in Colombia · NA · not yet recruiting
NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
NCT07534254 — Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05216952 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 28 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05216952.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing