Trial Outcomes & Findings for The Effects of Oxytocin in Obese Adults (NCT NCT03043053)
NCT ID: NCT03043053
Last Updated: 2024-02-07
Results Overview
The mean difference in weight loss between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline, Week 2, Week 4, Week 6, and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2024-02-07
Participant Flow
Participant milestones
| Measure |
Oxytocin
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
oxytocin nasal spray: oxytocin intranasal spray
|
Placebo
placebo nasal spray (4 times per day for 8 weeks)
Placebo: Placebo nasal spray
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
Started (mITT)
|
31
|
29
|
|
Overall Study
COMPLETED
|
28
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Oxytocin in Obese Adults
Baseline characteristics by cohort
| Measure |
Oxytocin
n=31 Participants
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
oxytocin nasal spray: oxytocin intranasal spray
|
Placebo
n=30 Participants
placebo nasal spray (4 times per day for 8 weeks)
Placebo: Placebo nasal spray
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 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
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Modified Intention-To-Treat cohort, which includes all randomly assigned participants who completed at least 1 visit on study drug.
The mean difference in weight loss between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline, Week 2, Week 4, Week 6, and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.
Outcome measures
| Measure |
Oxytocin
n=31 Participants
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
|
Placebo
n=29 Participants
placebo nasal spray (4 times per day for 8 weeks)
|
|---|---|---|
|
Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline
|
0.20 kilogram
|
0.26 kilogram
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Modified Intention-to-Treat cohort, which includes all randomly assigned participants who completed at least 1 visit on study drug.
The mean difference in resting energy expenditure between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female), obesity class (class I, II, and III), and lean mass to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group. Reported are model estimates rounded to one decimal.
Outcome measures
| Measure |
Oxytocin
n=31 Participants
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
|
Placebo
n=29 Participants
placebo nasal spray (4 times per day for 8 weeks)
|
|---|---|---|
|
Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo
|
-17.8 kilocalories/day
|
11.8 kilocalories/day
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: Modified Intention-To-Treat cohort, which includes all randomly assigned participants who completed at least 1 visit on study drug.
The mean difference in total fat mass between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.
Outcome measures
| Measure |
Oxytocin
n=31 Participants
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
|
Placebo
n=29 Participants
placebo nasal spray (4 times per day for 8 weeks)
|
|---|---|---|
|
Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo
|
248.5 gram
|
52.5 gram
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: Modified Intention-To-Treat cohort, which includes all randomly assigned participants who completed at least 1 visit on study drug.
The mean difference in caloric intake between oxytocin- and placebo-treated groups from baseline to 6 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 6) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.
Outcome measures
| Measure |
Oxytocin
n=31 Participants
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
|
Placebo
n=29 Participants
placebo nasal spray (4 times per day for 8 weeks)
|
|---|---|---|
|
Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo
|
-31.4 kilocalories
|
120.6 kilocalories
|
Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin
n=31 participants at risk
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
|
Placebo
n=30 participants at risk
placebo nasal spray (4 times per day for 8 weeks)
|
|---|---|---|
|
Investigations
Liver function test increased
|
6.5%
2/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
10.0%
3/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
General disorders
Chest pain
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
General disorders
Oedema
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Infections and infestations
COVID-19
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Infections and infestations
Gastrointestinal viral infection
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Infections and infestations
Influenza
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.5%
2/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Investigations
Blood glucose increased
|
12.9%
4/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
10.0%
3/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Investigations
Blood potassium increased
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Investigations
Electrocardiogram QT prolonged
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Metabolism and nutrition disorders
Thirst
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Nervous system disorders
Headache
|
16.1%
5/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
23.3%
7/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Nervous system disorders
Parasthesia
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Psychiatric disorders
Dysphoria
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Psychiatric disorders
Hypersomnia
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Renal and urinary disorders
Dysuria
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Renal and urinary disorders
Polyuria
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Reproductive system and breast disorders
Uterine pain
|
6.5%
2/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
10.0%
3/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
19.4%
6/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
6.5%
2/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
3.3%
1/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Skin and subcutaneous tissue disorders
Wound complication
|
6.5%
2/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
6.7%
2/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
|
Vascular disorders
Presyncope
|
3.2%
1/31 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
0.00%
0/30 • Baseline to Week 14 end of study
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment to the end of the study at Week 14.
|
Additional Information
Elizabeth A. Lawson, MD, MMSc
Massachusetts General Hospital
Phone: 617-726-3870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place