Trial Outcomes & Findings for Intervention to End Recurrent Unscheduled Bleeding Trial (NCT NCT03118297)
NCT ID: NCT03118297
Last Updated: 2018-08-31
Results Overview
To evaluate the effectiveness of ulipristal acetate (15mg) in decreasing bleeding/spotting days due to the ENG implant over a 30-day period as compared to placebo.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
65 participants
Primary outcome timeframe
30 days
Results posted on
2018-08-31
Participant Flow
Participant milestones
| Measure |
Ulipristal Acetate
15mg ulipristal acetate (capsule) daily for 7 days
Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
Placebo
Identical appearing placebo (capsule) daily for 7 days
Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Ulipristal Acetate
15mg ulipristal acetate (capsule) daily for 7 days
Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
Placebo
Identical appearing placebo (capsule) daily for 7 days
Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
2 participants lost to follow up in placebo group
Baseline characteristics by cohort
| Measure |
Ulipristal Acetate
n=32 Participants
15mg ulipristal acetate (capsule) daily for 7 days
Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
Placebo
n=33 Participants
Identical placebo (capsule) daily for 7 days
Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 6.2 • n=32 Participants • 2 participants lost to follow up in placebo group
|
25.5 years
STANDARD_DEVIATION 6.3 • n=31 Participants • 2 participants lost to follow up in placebo group
|
26.0 years
STANDARD_DEVIATION 6.2 • n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Sex: Female, Male
Female
|
32 Participants
n=32 Participants • 2 participants lost to follow up in placebo group
|
31 Participants
n=31 Participants • 2 participants lost to follow up in placebo group
|
63 Participants
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Sex: Female, Male
Male
|
0 Participants
n=32 Participants • 2 participants lost to follow up in placebo group
|
0 Participants
n=31 Participants • 2 participants lost to follow up in placebo group
|
0 Participants
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=32 Participants • 2 participants lost to follow up in placebo group
|
2 Participants
n=31 Participants • 2 participants lost to follow up in placebo group
|
2 Participants
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=32 Participants • 2 participants lost to follow up in placebo group
|
29 Participants
n=31 Participants • 2 participants lost to follow up in placebo group
|
61 Participants
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants • 2 participants lost to follow up in placebo group
|
0 Participants
n=31 Participants • 2 participants lost to follow up in placebo group
|
0 Participants
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Race/Ethnicity, Customized
Race · Black
|
20 Participants
n=32 Participants • 2 participants lost to follow up in placebo group
|
21 Participants
n=31 Participants • 2 participants lost to follow up in placebo group
|
41 Participants
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Race/Ethnicity, Customized
Race · White
|
7 Participants
n=32 Participants • 2 participants lost to follow up in placebo group
|
7 Participants
n=31 Participants • 2 participants lost to follow up in placebo group
|
14 Participants
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Race/Ethnicity, Customized
Race · Other or multiracial
|
5 Participants
n=32 Participants • 2 participants lost to follow up in placebo group
|
3 Participants
n=31 Participants • 2 participants lost to follow up in placebo group
|
8 Participants
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants • 2 participants lost to follow up in placebo group
|
31 participants
n=31 Participants • 2 participants lost to follow up in placebo group
|
63 participants
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
BMI
|
29.6 kg/m^2
STANDARD_DEVIATION 8.2 • n=32 Participants • 2 participants lost to follow up in placebo group
|
27.8 kg/m^2
STANDARD_DEVIATION 7.0 • n=31 Participants • 2 participants lost to follow up in placebo group
|
28.7 kg/m^2
STANDARD_DEVIATION 7.6 • n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Duration of implant use
|
10.9 months
n=32 Participants • 2 participants lost to follow up in placebo group
|
9.2 months
n=31 Participants • 2 participants lost to follow up in placebo group
|
10.1 months
n=63 Participants • 2 participants lost to follow up in placebo group
|
|
Days of bleeding in 30 days prior to enrollment
|
20.5 days
n=32 Participants • 2 participants lost to follow up in placebo group
|
20.0 days
n=31 Participants • 2 participants lost to follow up in placebo group
|
20.3 days
n=63 Participants • 2 participants lost to follow up in placebo group
|
PRIMARY outcome
Timeframe: 30 daysPopulation: See baseline characteristics
To evaluate the effectiveness of ulipristal acetate (15mg) in decreasing bleeding/spotting days due to the ENG implant over a 30-day period as compared to placebo.
Outcome measures
| Measure |
Ulipristal Acetate
n=32 Participants
15mg ulipristal acetate (capsule) daily for 7 days
Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
Placebo
n=31 Participants
Identical placebo (capsule) daily for 7 days
Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
|---|---|---|
|
Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries
|
7 days
Interval 4.5 to 11.0
|
12 days
Interval 6.0 to 21.0
|
SECONDARY outcome
Timeframe: 10 daysPopulation: See baseline characteristics
To evaluate bleeding cessation rates by day 10 following seven days of treatment with either ulipristal acetate or placebo.
Outcome measures
| Measure |
Ulipristal Acetate
n=32 Participants
15mg ulipristal acetate (capsule) daily for 7 days
Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
Placebo
n=31 Participants
Identical placebo (capsule) daily for 7 days
Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
|---|---|---|
|
Number of Participants With Bleeding Cessation by Day 10
|
11 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: See baseline characteristics
To evaluate participant satisfaction with regards to bleeding pattern after use of ulipristal acetate.
Outcome measures
| Measure |
Ulipristal Acetate
n=32 Participants
15mg ulipristal acetate (capsule) daily for 7 days
Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
Placebo
n=31 Participants
Identical placebo (capsule) daily for 7 days
Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
|---|---|---|
|
Participant Satisfaction With Bleeding Pattern at 30 Days
Not at all happy
|
0 Participants
|
7 Participants
|
|
Participant Satisfaction With Bleeding Pattern at 30 Days
Somewhat unhappy
|
0 Participants
|
2 Participants
|
|
Participant Satisfaction With Bleeding Pattern at 30 Days
Neither happy nor unhappy
|
4 Participants
|
3 Participants
|
|
Participant Satisfaction With Bleeding Pattern at 30 Days
Somewhat happy
|
5 Participants
|
10 Participants
|
|
Participant Satisfaction With Bleeding Pattern at 30 Days
Very happy
|
23 Participants
|
8 Participants
|
|
Participant Satisfaction With Bleeding Pattern at 30 Days
Did not respond
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: See baseline characteristics
To evaluate participant satisfaction with regards to medication side effects.
Outcome measures
| Measure |
Ulipristal Acetate
n=32 Participants
15mg ulipristal acetate (capsule) daily for 7 days
Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
Placebo
n=31 Participants
Identical placebo (capsule) daily for 7 days
Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
|---|---|---|
|
Number of Participants With Medication Side Effects by 30 Days
Dizziness
|
1 participants
|
1 participants
|
|
Number of Participants With Medication Side Effects by 30 Days
Headache
|
3 participants
|
6 participants
|
|
Number of Participants With Medication Side Effects by 30 Days
Nausea/Vomiting
|
1 participants
|
3 participants
|
|
Number of Participants With Medication Side Effects by 30 Days
Feeling flushed
|
0 participants
|
1 participants
|
|
Number of Participants With Medication Side Effects by 30 Days
Abdominal pain
|
2 participants
|
2 participants
|
|
Number of Participants With Medication Side Effects by 30 Days
Other
|
1 participants
|
1 participants
|
|
Number of Participants With Medication Side Effects by 30 Days
Did not experience
|
26 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 1, 2, 3, 4Population: See baseline characteristics
To evaluate effect, if any, of ulipristal acetate on ovulation status. Data in the table represent the lowest and highest values that were recorded over all of the measurements for each arm as a whole.
Outcome measures
| Measure |
Ulipristal Acetate
n=32 Participants
15mg ulipristal acetate (capsule) daily for 7 days
Ulipristal Acetate: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
Placebo
n=31 Participants
Identical placebo (capsule) daily for 7 days
Placebo oral capsule: Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
|
|---|---|---|
|
Ovulation Status Measured by Weekly Serum Progesterone Levels
Lower endpoint
|
0.0 ng/mL
|
0.0 ng/mL
|
|
Ovulation Status Measured by Weekly Serum Progesterone Levels
Upper endpoint
|
4.4 ng/mL
|
1.3 ng/mL
|
Adverse Events
Ulipristal Acetate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Intervention To End Recurrent Unscheduled bleeding Trial (INTERRUPT): A randomized-controlled trial
WashingtonU
Phone: 3143228697
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place