Trial Outcomes & Findings for The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity (NCT NCT03119610)
NCT ID: NCT03119610
Last Updated: 2021-10-22
Results Overview
Intranasal oxytocin will promote weight loss and preserve muscle mass
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2021-10-22
Participant Flow
Participant milestones
| Measure |
Oxytocin Nasal Spray
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Oxytocin Nasal Spray
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
Baseline characteristics by cohort
| Measure |
Oxytocin Nasal Spray
n=13 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=10 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, 60 or over
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Two participants withdrew after randomization; 1 in Oxytocin and 1 in Placebo group. Data from these two subjects were not collected.
Intranasal oxytocin will promote weight loss and preserve muscle mass
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Body Weight
|
0.54 Kilograms
Standard Deviation 1.6
|
0.04 Kilograms
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements of fat mass by dual energy x-ray absorptiometry (DXA) will be examined for individual change with intranasal oxytocin
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Fat Mass
|
-0.2 Kilograms
Standard Deviation 0.99
|
-0.1 Kilograms
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 8 weeksPre- and post-measurements of lean mass by DXA will be examined for individual change with intranasal oxytocin. Change in body mass index (BMI).
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Body Mass Index
|
36.8 kg/m2
Standard Deviation 3.5
|
36.8 kg/m2
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 8 weeksPre- and post-measurements of oral glucose tolerance test for 2-hour plasma glucose will be examined for individual change with intranasal oxytocin
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Glucose Levels Measured Using the Glucose Tolerance Test
Fasting glucose
|
3.36 mg/dL
Standard Deviation 10.18
|
2.85 mg/dL
Standard Deviation 6.28
|
|
Change in Glucose Levels Measured Using the Glucose Tolerance Test
2-hour glucose
|
-3.15 mg/dL
Standard Deviation 31.126
|
-3.375 mg/dL
Standard Deviation 14.88
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements will be examined for individual change with intranasal oxytocin. This battery of tests is scored on a scale with 3 SPPB calculation components: 1. Ability to stand for 10 seconds with feet in 3 different positions, scored from 0 min to 4 maximum, with a higher score indicating better balance.(3 Balance subsets: side by side stand scored from 0-1; semi-tandem stance scored from 0-1; tandem stance scored from 0-2) 2. Two timed trials of a 3m or 4 m walk (fastest recorded). Scoring is from 0-4, with 0 being unable to walk and 4 indicating a faster walk time. 3. Time to rise from a chair five times is scored from 0-4, with 0 being unable to complete the activity, and 4 indicating that time to complete is less than 11.1 seconds. Total Score is the sum of all 3 scores: Minimum = 0 Maximum = 12. Higher scores indicate better lower extremity function. Difference between baseline and 8 week performance is reported.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Short Physical Performance Battery (SPPB)
|
0.5 score on a scale
Standard Deviation 1.446
|
0.625 score on a scale
Standard Deviation 1.598
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements will be examined for individual change with intranasal oxytocin
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in HbA1c (Hemoglobin A1c)
|
-0.05 Percentage
Standard Deviation 0.1857
|
0.286 Percentage
Standard Deviation 0.1254
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements will be examined for individual change with intranasal oxytocin
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Waist Circumference
|
-0.6958 centimeteres
Standard Deviation 4.8662
|
-1.373 centimeteres
Standard Deviation 2.1997
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements will be examined for individual change with intranasal oxytocin
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Total Cholesterol
|
-11.18 mg/dL
Standard Deviation 17.417
|
-1.143 mg/dL
Standard Deviation 16.056
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements will be examined for individual change with intranasal oxytocin
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Low Density Lipoproteins (LDL)
|
-8.727 mg/dL
Standard Deviation 16.224
|
4.1429 mg/dL
Standard Deviation 11.539
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements will be examined for individual change with intranasal oxytocin
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in High Density Lipoproteins (HDL)
|
1.000 mg/dL
Standard Deviation 2.8983
|
0.1429 mg/dL
Standard Deviation 3.8408
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements will be examined for individual change with intranasal oxytocin
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Triglycerides
|
-16.82 mg/dL
Standard Deviation 23.828
|
-26.29 mg/dL
Standard Deviation 46.903
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements will be examined for individual change with intranasal oxytocin. This is measured on a 20 item scale using the following scoring using number of week days: 1. Rarely or none of the time ( less than 1 day) 2. Some or a little of the time (1-2 days) 3. Occasionally or a moderate amount of time (3-4 days) 4. Most or all of the time (5-7 days) SCORING: zero for answers =1), 1 for answers =2), 2 for answers =3) column, 3 for answers =4) The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Center for Epidemiologic Studies Scale (CES-D)
|
-1.375 score on a scale
Standard Deviation 2.1860
|
0.2222 score on a scale
Standard Deviation 2.7285
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPre- and post-measurements will be examined for individual change with intranasal oxytocin. A 30-point test, with a score of 0 or 1 assigned to each item. The minimum score is 0 and the maximum is 30. The higher the score, the less cognitive impairment.
Outcome measures
| Measure |
Oxytocin Nasal Spray
n=12 Participants
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 Participants
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA)
|
1.0000 score on a scale
Standard Deviation 1.5954
|
0.4444 score on a scale
Standard Deviation 1.3333
|
Adverse Events
Oxytocin Nasal Spray
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Nasal Spray
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin Nasal Spray
n=12 participants at risk
Oxytocin (Syntocinon), intranasal, 24IU, 4x a day for 8 weeks, self administered
Oxytocin nasal spray: Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray)
|
Placebo Nasal Spray
n=9 participants at risk
Placebo nasal spray, 4x a day for 8 weeks, self administered
Placebo nasal spray: Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
58.3%
7/12 • Number of events 7 • 8 weeks
|
22.2%
2/9 • Number of events 2 • 8 weeks
|
|
Nervous system disorders
Headache
|
33.3%
4/12 • Number of events 4 • 8 weeks
|
33.3%
3/9 • Number of events 3 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • Number of events 5 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
41.7%
5/12 • Number of events 5 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
General disorders
Fatigue
|
0.00%
0/12 • 8 weeks
|
22.2%
2/9 • Number of events 2 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Irritation
|
16.7%
2/12 • Number of events 2 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
General disorders
Tiredness
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
General disorders
Malaise
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
General disorders
Chills
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
General disorders
Flu like symptoms
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Lightheaded
|
16.7%
2/12 • Number of events 2 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
16.7%
2/12 • Number of events 2 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Nervous system disorders
Confusion
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Nervous system disorders
Delirium
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
General disorders
Irritability
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Vascular disorders
Bruise related to biopsy
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Gastrointestinal disorders
Upset stomach
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms, hands
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms, legs
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Anorexia
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Gastrointestinal disorders
Decreased Appetite
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Nervous system disorders
Migraine
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat itching
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/9 • 8 weeks
|
|
General disorders
Fever
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Loose stool
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Increased bowel movement
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
|
Renal and urinary disorders
Bladder disturbance
|
0.00%
0/12 • 8 weeks
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place