Trial Outcomes & Findings for Ulipristal Acetate for Use in Early Pregnancy Loss (NCT NCT05216952)
NCT ID: NCT05216952
Last Updated: 2023-06-28
Results Overview
Measured as number of participants enrolled in study divided by number of patients screened for participation in study
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Baseline
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
Ulipristal Acetate (UPA) 90 mg
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ulipristal Acetate for Use in Early Pregnancy Loss
Baseline characteristics by cohort
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The number of potential participants screened for study eligibility.
Measured as number of participants enrolled in study divided by number of patients screened for participation in study
Outcome measures
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=8 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
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|---|---|
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Percentage of Participants Recruited to Study Protocol
|
37.5 percentage of participants
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PRIMARY outcome
Timeframe: From admission until day 3 follow up, +/- 1 dayMeasured 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.
Outcome measures
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
|
|---|---|
|
Percentage of Participants Adherent to Study Protocol
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: From admission until day 30 follow up, +/- 7 daysMeasured 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
Outcome measures
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
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|---|---|
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Percentage of Participants Retained in Study Protocol
|
100 percentage of participants
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SECONDARY outcome
Timeframe: From admission until day 3 follow up, +/- 1 dayAbsence of gestational sac on transvaginal ultrasound examination on day 3 follow up
Outcome measures
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
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|---|---|
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Number of Participants With Resolution of Early Pregnancy Loss Following Study Intervention
|
3 Participants
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SECONDARY outcome
Timeframe: From admission until day 30 follow up, +/- 7 daysParticipant 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.
Outcome measures
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
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|---|---|
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Number of Participants With Treatment-Related Side Effects
Fatigue
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2 Participants
|
|
Number of Participants With Treatment-Related Side Effects
Headache
|
0 Participants
|
|
Number of Participants With Treatment-Related Side Effects
Dizziness
|
2 Participants
|
|
Number of Participants With Treatment-Related Side Effects
Chills
|
1 Participants
|
|
Number of Participants With Treatment-Related Side Effects
Nausea
|
1 Participants
|
|
Number of Participants With Treatment-Related Side Effects
Diarrhea
|
0 Participants
|
|
Number of Participants With Treatment-Related Side Effects
Vomiting
|
0 Participants
|
|
Number of Participants With Treatment-Related Side Effects
Severe cramping
|
1 Participants
|
|
Number of Participants With Treatment-Related Side Effects
Fever
|
0 Participants
|
SECONDARY outcome
Timeframe: From admission until day 30 follow up, +/- 7 daysParticipant 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.
Outcome measures
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events
Bleeding requiring hospitalization and/or blood transfusion
|
1 Participants
|
|
Number of Participants With Treatment-Related Adverse Events
Pelvic infection requiring hospitalization and/or antibiotics
|
0 Participants
|
|
Number of Participants With Treatment-Related Adverse Events
Other
|
0 Participants
|
SECONDARY outcome
Timeframe: From admission until day 30 follow up, +/- 7 daysParticipant 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.
Outcome measures
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
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|---|---|
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Median Acceptability of Study Intervention
Would you use these medications again if you had another miscarriage?
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3 score on a scale
Interval 1.0 to 5.0
|
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Median Acceptability of Study Intervention
Would you recommend these medications to a friend with a miscarriage?
|
4 score on a scale
Interval 3.0 to 5.0
|
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Median Acceptability of Study Intervention
If possible to take Ulipristal Acetate (UPA) at home, would you be more or less likely to use again?
|
4 score on a scale
Interval 3.0 to 4.0
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|
Median Acceptability of Study Intervention
If possible to take UPA at a different time, would you be more or less likely to use again?
|
3 score on a scale
Interval 3.0 to 4.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: From admission until day 30 follow up, +/- 7 daysParticipant reported need for additional dose of misoprostol for resolution of early pregnancy loss.
Outcome measures
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
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|---|---|
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Number of Participants Needing Additional Medication for Resolution of Early Pregnancy Loss
|
0 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: From admission until day 30 follow up, +/- 7 daysParticipant reported need for vacuum aspiration for resolution of early pregnancy loss.
Outcome measures
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 Participants
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
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|---|---|
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Number of Participants Needing Surgical Management for Resolution of Early Pregnancy Loss
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0 Participants
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Adverse Events
Ulipristal Acetate (UPA) 90 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 participants at risk
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
|
|---|---|
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Pregnancy, puerperium and perinatal conditions
Vaginal Bleeding Requiring Hospitalization
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, 30 days +/- 7 days.
|
Other adverse events
| Measure |
Ulipristal Acetate (UPA) 90 mg
n=3 participants at risk
Participants receive ulipristal acetate 90 mg PO followed by self-administration of misoprostol 800 mcg vaginally 6 to 18 hours following ulipristal acetate administration.
Ulipristal Acetate Tablets: 90 mg (three 30 mg tablets) administered orally once
Misoprostol Pill: 800 mcg (four 200 mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
|
|---|---|
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General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • From the time of signing informed consent through study completion, 30 days +/- 7 days.
|
|
General disorders
Dizziness
|
66.7%
2/3 • Number of events 2 • From the time of signing informed consent through study completion, 30 days +/- 7 days.
|
|
Infections and infestations
Chills
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, 30 days +/- 7 days.
|
|
Reproductive system and breast disorders
Severe cramping
|
33.3%
1/3 • Number of events 2 • From the time of signing informed consent through study completion, 30 days +/- 7 days.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • From the time of signing informed consent through study completion, 30 days +/- 7 days.
|
Additional Information
Jill Hagey, MD, MPH
University of North Carolina at Chapel Hill
Phone: 919-966-5280
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place