Trial Outcomes & Findings for The Efficacy and Safety of a Selective Estrogen Receptor Beta Agonist (LY500307) for Negative Symptoms and Cognitive Impairment Associated With Schizophrenia (NCT NCT01874756)
NCT ID: NCT01874756
Last Updated: 2019-07-02
Results Overview
The Negative Symptom Assessment Scale - 16-item (NSA-16) is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates subjects on 16 "anchors," is a semi-structured, clinical interview, and each item is rated from 1 to 6. The total score is the sum of the 16 specific items and ranges from 16 to 96; a higher score indicates greater severity of illness. In addition, there is a global rating that represents the overall assessment of a subject's negative symptoms. The rating should not be an average of any particular behavior, but a gestalt of everything observed in the interview.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
Baseline, week 2, week 4, week 6, week 8
Results posted on
2019-07-02
Participant Flow
Participant milestones
| Measure |
Placebo
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 25mg
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
LY500307 75mg
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 150mg
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
10
|
29
|
27
|
|
Overall Study
COMPLETED
|
28
|
10
|
27
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy and Safety of a Selective Estrogen Receptor Beta Agonist (LY500307) for Negative Symptoms and Cognitive Impairment Associated With Schizophrenia
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 25mg
n=10 Participants
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
LY500307 75mg
n=29 Participants
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 150mg
n=25 Participants
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
Total
n=93 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
36.28 years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
36.64 years
STANDARD_DEVIATION 12.58 • n=7 Participants
|
37.15 years
STANDARD_DEVIATION 13.67 • n=5 Participants
|
37.64 years
STANDARD_DEVIATION 10.21 • n=4 Participants
|
37.07 years
STANDARD_DEVIATION 12.18 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
10 participants
n=7 Participants
|
29 participants
n=5 Participants
|
25 participants
n=4 Participants
|
93 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 2, week 4, week 6, week 8The Negative Symptom Assessment Scale - 16-item (NSA-16) is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates subjects on 16 "anchors," is a semi-structured, clinical interview, and each item is rated from 1 to 6. The total score is the sum of the 16 specific items and ranges from 16 to 96; a higher score indicates greater severity of illness. In addition, there is a global rating that represents the overall assessment of a subject's negative symptoms. The rating should not be an average of any particular behavior, but a gestalt of everything observed in the interview.
Outcome measures
| Measure |
LY500307 150mg
n=25 Participants
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
Placebo
n=29 Participants
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 75mg
n=29 Participants
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 25mg
n=10 Participants
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
|---|---|---|---|---|
|
Negative Symptom Changes - Negative Symptom Assessment Scale - 16-item (NSA-16) Total Score
Baseline
|
42.52 score on a scale
Standard Deviation 11.05
|
45.34 score on a scale
Standard Deviation 12.03
|
45.93 score on a scale
Standard Deviation 13.99
|
46.10 score on a scale
Standard Deviation 12.60
|
|
Negative Symptom Changes - Negative Symptom Assessment Scale - 16-item (NSA-16) Total Score
Week 2
|
40.96 score on a scale
Standard Deviation 12.82
|
46.10 score on a scale
Standard Deviation 14.68
|
44.82 score on a scale
Standard Deviation 11.62
|
47.20 score on a scale
Standard Deviation 14.69
|
|
Negative Symptom Changes - Negative Symptom Assessment Scale - 16-item (NSA-16) Total Score
Week 4
|
41.35 score on a scale
Standard Deviation 12.38
|
48.21 score on a scale
Standard Deviation 14.32
|
45.30 score on a scale
Standard Deviation 12.16
|
45.80 score on a scale
Standard Deviation 13.41
|
|
Negative Symptom Changes - Negative Symptom Assessment Scale - 16-item (NSA-16) Total Score
Week 6
|
43.43 score on a scale
Standard Deviation 15.36
|
46.46 score on a scale
Standard Deviation 15.64
|
43.19 score on a scale
Standard Deviation 11.18
|
44.10 score on a scale
Standard Deviation 15.74
|
|
Negative Symptom Changes - Negative Symptom Assessment Scale - 16-item (NSA-16) Total Score
Week 8
|
42.90 score on a scale
Standard Deviation 14.09
|
47.79 score on a scale
Standard Deviation 16.26
|
44.12 score on a scale
Standard Deviation 12.72
|
44.50 score on a scale
Standard Deviation 13.56
|
PRIMARY outcome
Timeframe: Baseline, week 2, week 4, week 6, week 8Working memory (composite score of the Wechsler Memory Scale-III: Spatial Span (WMS) and Letter Number Span (LNS) tests). WMS has 2 sections in which a subject recalls increasingly difficult sequences. The total raw score range for both sections is 0-32. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. LNS consists of 24 increasingly difficult sequences of letters and numbers that a subject is to recall and repeat back in Numeric-Alpha sequential order. The total raw score range is 0-24. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. The Working Memory composite score is calculated by summing the WMS and LNS tscores, ranging from 0-200, a higher tscore reflects better performance.
Outcome measures
| Measure |
LY500307 150mg
n=25 Participants
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
Placebo
n=29 Participants
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 75mg
n=29 Participants
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 25mg
n=10 Participants
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
|---|---|---|---|---|
|
Working Memory Composite Score Changes
Baseline
|
34.76 score on a scale
Standard Deviation 12.03
|
33.21 score on a scale
Standard Deviation 11.86
|
34.79 score on a scale
Standard Deviation 10.90
|
35.70 score on a scale
Standard Deviation 14.88
|
|
Working Memory Composite Score Changes
Week 2
|
35.70 score on a scale
Standard Deviation 10.68
|
36.41 score on a scale
Standard Deviation 12.55
|
36.89 score on a scale
Standard Deviation 8.94
|
36.50 score on a scale
Standard Deviation 13.09
|
|
Working Memory Composite Score Changes
Week 4
|
35.30 score on a scale
Standard Deviation 13.08
|
35.93 score on a scale
Standard Deviation 12.14
|
37.54 score on a scale
Standard Deviation 8.66
|
35.90 score on a scale
Standard Deviation 13.49
|
|
Working Memory Composite Score Changes
Week 6
|
37.13 score on a scale
Standard Deviation 11.43
|
36.00 score on a scale
Standard Deviation 10.99
|
38.54 score on a scale
Standard Deviation 9.63
|
37.20 score on a scale
Standard Deviation 13.37
|
|
Working Memory Composite Score Changes
Week 8
|
37.86 score on a scale
Standard Deviation 11.24
|
38.04 score on a scale
Standard Deviation 13.08
|
37.48 score on a scale
Standard Deviation 9.18
|
38.00 score on a scale
Standard Deviation 12.27
|
PRIMARY outcome
Timeframe: Baseline, week 2, week 4, week 6, week 8Verbal learning (composite score of the Hopkins Verbal Learning Test-Revised (HVLT-R)). The HVLT-R has 3 trials in which a subject recalls has many words from a list of 12 as they can. The total number recalled for each trial is summed and the score range is between 0-36. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. The verbal learning composite score is calculated by using the HVLT-R tscore, a higher tscore reflects better performance.
Outcome measures
| Measure |
LY500307 150mg
n=25 Participants
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
Placebo
n=29 Participants
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 75mg
n=29 Participants
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 25mg
n=10 Participants
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
|---|---|---|---|---|
|
Verbal Learning Composite Score Changes
Baseline
|
33.36 score on a scale
Standard Deviation 6.60
|
33.93 score on a scale
Standard Deviation 5.98
|
34.50 score on a scale
Standard Deviation 7.39
|
32.30 score on a scale
Standard Deviation 6.63
|
|
Verbal Learning Composite Score Changes
Week 2
|
34.17 score on a scale
Standard Deviation 6.97
|
35.41 score on a scale
Standard Deviation 8.73
|
37.11 score on a scale
Standard Deviation 8.22
|
34.20 score on a scale
Standard Deviation 4.87
|
|
Verbal Learning Composite Score Changes
Week 4
|
33.96 score on a scale
Standard Deviation 7.04
|
35.11 score on a scale
Standard Deviation 7.43
|
37.42 score on a scale
Standard Deviation 8.26
|
34.60 score on a scale
Standard Deviation 5.52
|
|
Verbal Learning Composite Score Changes
Week 6
|
33.74 score on a scale
Standard Deviation 6.78
|
34.44 score on a scale
Standard Deviation 7.84
|
34.62 score on a scale
Standard Deviation 7.13
|
33.40 score on a scale
Standard Deviation 6.28
|
|
Verbal Learning Composite Score Changes
Week 8
|
34.67 score on a scale
Standard Deviation 5.63
|
35.54 score on a scale
Standard Deviation 7.57
|
37.12 score on a scale
Standard Deviation 7.76
|
37.30 score on a scale
Standard Deviation 6.17
|
PRIMARY outcome
Timeframe: week 2, week 4, week 8Number of subjects with total testosterone reduction, as defined as a decrease in total testosterone plasma concentrations of 50% from baseline for two consecutive post-randomization values
Outcome measures
| Measure |
LY500307 150mg
n=25 Participants
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
Placebo
n=29 Participants
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 75mg
n=29 Participants
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 25mg
n=10 Participants
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
|---|---|---|---|---|
|
Number of Subjects With Total Testosterone Reduction
Week 2
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Total Testosterone Reduction
Week 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Total Testosterone Reduction
Week 8
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Week 4, Week 8Number of subjects with QTc prolongation, as defined as any subject with a change from baseline of 60 msec or greater during the active treatment phases
Outcome measures
| Measure |
LY500307 150mg
n=25 Participants
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
Placebo
n=29 Participants
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 75mg
n=29 Participants
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 25mg
n=10 Participants
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
|---|---|---|---|---|
|
Number of Subjects With QTc Prolongation
Week 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With QTc Prolongation
Week 8
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksTo determine if LY500307 demonstrates cortical target engagement as assessed by changes in the N-back in frontal-parietal regions during the MRI.
Outcome measures
| Measure |
LY500307 150mg
n=25 Participants
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
Placebo
n=29 Participants
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 75mg
n=29 Participants
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 25mg
n=10 Participants
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
|---|---|---|---|---|
|
Cortical Target Engagement
Baseline
|
0.15 beta coefficient
Standard Deviation 0.22
|
0.16 beta coefficient
Standard Deviation 0.22
|
0.27 beta coefficient
Standard Deviation 0.21
|
0.21 beta coefficient
Standard Deviation 0.20
|
|
Cortical Target Engagement
Week 8
|
0.26 beta coefficient
Standard Deviation 0.21
|
0.22 beta coefficient
Standard Deviation 0.22
|
0.31 beta coefficient
Standard Deviation 0.26
|
0.30 beta coefficient
Standard Deviation 0.22
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
LY500307 25mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY500307 75mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY500307 150mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=29 participants at risk
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 25mg
n=10 participants at risk
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
LY500307 75mg
n=29 participants at risk
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 150mg
n=25 participants at risk
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
|---|---|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/10 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
|
Blood and lymphatic system disorders
Hematemesis
|
3.4%
1/29 • Number of events 1 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/10 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/25 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
Other adverse events
| Measure |
Placebo
n=29 participants at risk
placebo 6 pills of inactive drug
Placebo: 6 placebo capsules daily for 8 weeks
|
LY500307 25mg
n=10 participants at risk
LY500307 25mg
LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
|
LY500307 75mg
n=29 participants at risk
LY500307 75mg
LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
|
LY500307 150mg
n=25 participants at risk
LY500307 150mg
LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
|
|---|---|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
6.9%
2/29 • Number of events 2 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/10 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/25 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
|
Infections and infestations
Upper Respiratory Infection
|
6.9%
2/29 • Number of events 2 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/10 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
3.4%
1/29 • Number of events 1 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/25 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/10 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
6.9%
2/29 • Number of events 2 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/25 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/10 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
|
Renal and urinary disorders
Increased Urinary Frequency
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/10 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
|
Psychiatric disorders
Psychotic Exacerbation
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/10 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
0.00%
0/29 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place