Trial Outcomes & Findings for Botulinum Toxin for Pelvic Pain in Women With Endometriosis (NCT NCT01553201)
NCT ID: NCT01553201
Last Updated: 2020-07-28
Results Overview
Self reported improvement in pain symptoms - a binary measurement of improvement/no improvement
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
1 month
Results posted on
2020-07-28
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin (BoNT)
OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
|
Placebo
Saline, 4cc, one time intramuscular administration
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Botulinum Toxin for Pelvic Pain in Women With Endometriosis
Baseline characteristics by cohort
| Measure |
Botulinum Toxin (BoNT)
n=15 Participants
OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
|
Placebo
n=14 Participants
Saline, 4cc, one time intramuscular administration
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthSelf reported improvement in pain symptoms - a binary measurement of improvement/no improvement
Outcome measures
| Measure |
Botulinum Toxin (BoNT)
n=15 Participants
OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
|
Placebo
n=14 Participants
Saline, 4cc, one time intramuscular administration
|
|---|---|---|
|
Number of Participants With Improvement in Pain
|
11 Participants
|
4 Participants
|
Adverse Events
Botulinum Toxin (BoNT)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Botulinum Toxin (BoNT)
n=15 participants at risk
OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
|
Placebo
n=15 participants at risk
Saline, 4cc, one time intramuscular administration
|
|---|---|---|
|
Nervous system disorders
Muscular weakness
|
0.00%
0/15 • 1 month
|
6.7%
1/15 • Number of events 1 • 1 month
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • Number of events 1 • 1 month
|
6.7%
1/15 • Number of events 1 • 1 month
|
|
Renal and urinary disorders
Urinary hesitation
|
13.3%
2/15 • Number of events 2 • 1 month
|
0.00%
0/15 • 1 month
|
|
Renal and urinary disorders
Micturition urgency
|
6.7%
1/15 • Number of events 1 • 1 month
|
0.00%
0/15 • 1 month
|
|
Nervous system disorders
Pelvic pain
|
20.0%
3/15 • Number of events 3 • 1 month
|
0.00%
0/15 • 1 month
|
Additional Information
Barbara Karp, MD
National Institute of Neurological Disorders & Stroke
Phone: 301-496-0150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place