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Botulinum Toxin for Pelvic Pain in Women With Endometriosis

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ClinicalTrials.gov Identifier: NCT01553201
Recruitment Status : Completed
First Posted : March 14, 2012
Results First Posted : July 8, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Endometriosis
Chronic Pelvic Pain
Pelvic Muscle Spasm
Quality of Life
Interventions Drug: Botulinum toxin (BoNT)
Drug: Placebo
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin (BoNT) Placebo
Hide Arm/Group Description OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration Saline, 4cc, one time intramuscular administration
Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Botulinum Toxin (BoNT) Placebo Total
Hide Arm/Group Description OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration Saline, 4cc, one time intramuscular administration Total of all reporting groups
Overall Number of Baseline Participants 15 14 29
Hide Baseline Analysis Population Description
One subject in the placebo arm completed the study but her data was censored (i.e. not analyzed) on recommendation by the DSMB statistician, as she was one of a sister pair.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
14
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
Female
15
 100.0%
14
 100.0%
29
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
Hispanic or Latino
1
   6.7%
3
  21.4%
4
  13.8%
Not Hispanic or Latino
14
  93.3%
11
  78.6%
25
  86.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.7%
0
   0.0%
1
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  20.0%
0
   0.0%
3
  10.3%
White
10
  66.7%
13
  92.9%
23
  79.3%
More than one race
1
   6.7%
1
   7.1%
2
   6.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Improvement in Pain
Hide Description Self reported improvement in pain symptoms - a binary measurement of improvement/no improvement
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botulinum Toxin (BoNT) Placebo
Hide Arm/Group Description:
OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
Saline, 4cc, one time intramuscular administration
Overall Number of Participants Analyzed 15 14
Measure Type: Count of Participants
Unit of Measure: Participants
11
  73.3%
4
  28.6%
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botulinum Toxin (BoNT) Placebo
Hide Arm/Group Description OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration Saline, 4cc, one time intramuscular administration
All-Cause Mortality
Botulinum Toxin (BoNT) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
Botulinum Toxin (BoNT) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Botulinum Toxin (BoNT) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/15 (46.67%)      2/15 (13.33%)    
Nervous system disorders     
Muscular weakness   0/15 (0.00%)  0 1/15 (6.67%)  1
Migraine   1/15 (6.67%)  1 1/15 (6.67%)  1
Pelvic pain   3/15 (20.00%)  3 0/15 (0.00%)  0
Renal and urinary disorders     
Urinary hesitation   2/15 (13.33%)  2 0/15 (0.00%)  0
Micturition urgency   1/15 (6.67%)  1 0/15 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Barbara Karp, MD
Organization: National Institute of Neurological Disorders & Stroke
Phone: 301-496-0150
EMail: karpb@ninds.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01553201    
Other Study ID Numbers: 120083
12-N-0083
First Submitted: March 10, 2012
First Posted: March 14, 2012
Results First Submitted: June 30, 2020
Results First Posted: July 8, 2020
Last Update Posted: July 28, 2020