Trial Outcomes & Findings for Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS) (NCT NCT00939120)
NCT ID: NCT00939120
Last Updated: 2015-05-01
Results Overview
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
12 months
Results posted on
2015-05-01
Participant Flow
Participant milestones
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
Baseline characteristics by cohort
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
68.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 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
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Prostate volume
|
43.9 mL
STANDARD_DEVIATION 15.8 • n=5 Participants
|
43.1 mL
STANDARD_DEVIATION 16.0 • n=7 Participants
|
43.5 mL
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Prostate specific antigen
|
4.0 ng/mL
STANDARD_DEVIATION 2.1 • n=5 Participants
|
5.3 ng/mL
STANDARD_DEVIATION 8.8 • n=7 Participants
|
4.6 ng/mL
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Voided volume
|
202.5 mL
STANDARD_DEVIATION 96.5 • n=5 Participants
|
273.7 mL
STANDARD_DEVIATION 189.9 • n=7 Participants
|
238.1 mL
STANDARD_DEVIATION 153.2 • n=5 Participants
|
|
Maximum flow rate
|
11.1 mL/sec
STANDARD_DEVIATION 3.5 • n=5 Participants
|
12.4 mL/sec
STANDARD_DEVIATION 4.8 • n=7 Participants
|
11.7 mL/sec
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Post-void residual volume
|
93.0 mL
STANDARD_DEVIATION 69.2 • n=5 Participants
|
81.6 mL
STANDARD_DEVIATION 60.7 • n=7 Participants
|
87.3 mL
STANDARD_DEVIATION 64.6 • n=5 Participants
|
|
Overactive bladder questionnaire
|
86.4 units on a scale
STANDARD_DEVIATION 22.3 • n=5 Participants
|
86.1 units on a scale
STANDARD_DEVIATION 29.9 • n=7 Participants
|
86.3 units on a scale
STANDARD_DEVIATION 26.1 • n=5 Participants
|
|
Patient's perception of bladder condition
|
3.7 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
International prostate symptoms score, total
|
18.0 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
International prostate symptoms score, voiding subscore
|
9.1 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
International prostate symptoms score, storage subscore
|
8.9 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
8.7 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Urinary urgency
|
6.7 urgency episodes
STANDARD_DEVIATION 3.5 • n=5 Participants
|
8.6 urgency episodes
STANDARD_DEVIATION 3.5 • n=7 Participants
|
7.7 urgency episodes
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Urinary frequency
|
11.3 frequency episodes
STANDARD_DEVIATION 2.2 • n=5 Participants
|
11.4 frequency episodes
STANDARD_DEVIATION 2.2 • n=7 Participants
|
11.3 frequency episodes
STANDARD_DEVIATION 2.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Last data point carried forward for participants who were randomized and dropped prior to study end.
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.
Outcome measures
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
Post-void Residual (PVR) Volume
|
101.7 mL
Standard Error 22.4
|
75.8 mL
Standard Error 9.6
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Last data point carried forward for participants who were randomized and dropped prior to study end.
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.
Outcome measures
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
Maximum Urine Flow Rate (Qmax).
|
11.7 mL/sec
Standard Error 0.7
|
12.9 mL/sec
Standard Error 1.7
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Last data point carried forward for participants who were randomized and dropped prior to study end.
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.
Outcome measures
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
Urine Voided Volume (Voiding)
|
219.9 mL
Standard Error 20.6
|
232.9 mL
Standard Error 32.3
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Last data point carried forward for participants who were randomized and dropped prior to study end.
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.
Outcome measures
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
Acute Urinary Retention (AUR)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Last data point carried forward for participants who were randomized and dropped prior to study end.
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.
Outcome measures
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
Overactive Bladder Questionnaire (OABq)
|
80.2 units on a scale
Standard Error 5.8
|
67.7 units on a scale
Standard Error 5.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Last data point carried forward for participants who were randomized and dropped prior to study end.
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms.
Outcome measures
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
Patient Perception of Bladder Condition (PPBC)
|
3.6 units on a scale
Standard Error 0.3
|
3.0 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Last data point carried forward for participants who were randomized and dropped prior to study end.
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35.
Outcome measures
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
International Prostate Symptoms Score (IPSS), Total
|
15.4 units on a scale
Standard Error 1.4
|
14.5 units on a scale
Standard Error 1.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Last data point carried forward for participants who were randomized and dropped prior to study end.
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20.
Outcome measures
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
International Prostate Symptoms Score, Voiding Subscore
|
7.5 units on a scale
Standard Error 1.0
|
7.0 units on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Last data point carried forward for participants who were randomized and dropped prior to study end.
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15.
Outcome measures
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 Participants
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 Participants
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
International Prostate Symptoms Score (IPSS), Storage Subscore
|
7.9 units on a scale
Standard Error 0.7
|
7.5 units on a scale
Standard Error 0.6
|
Adverse Events
Tolterodine ER 4mg + Dutasteride 0.5mg
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo + Dutasteride 0.5mg
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 participants at risk
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 participants at risk
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
Nervous system disorders
Transient ischemic attacks
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal airway obstruction
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Renal and urinary disorders
Kidney stone
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Hepatobiliary disorders
Gallstones
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mass on kidney
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Nervous system disorders
Cervical stenosis
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Gastrointestinal disorders
Oral thrush
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Gastrointestinal disorders
Schatzki ring
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Gastrointestinal disorders
Presbyesophagus, dysphagia
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Gastrointestinal disorders
Hiatal hernia
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Psychiatric disorders
Suicidal self-inflicted gunshot wound, lethal
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Gastrointestinal disorders
Gastropathy
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.3%
1/23 • Number of events 1 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
Other adverse events
| Measure |
Tolterodine ER 4mg + Dutasteride 0.5mg
n=23 participants at risk
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
|
Placebo + Dutasteride 0.5mg
n=23 participants at risk
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
|
|---|---|---|
|
Cardiac disorders
Angina
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Endocrine disorders
Diabetes
|
4.3%
1/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Reproductive system and breast disorders
Gynecomastia
|
4.3%
1/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
13.0%
3/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Reproductive system and breast disorders
Breast tenderness
|
17.4%
4/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Blood and lymphatic system disorders
Epistaxis
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Renal and urinary disorders
Difficulty urinating
|
13.0%
3/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Renal and urinary disorders
Urinary urgency / incontinence
|
21.7%
5/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
URI / sinusitis / rhinitis
|
34.8%
8/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
52.2%
12/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Ear and labyrinth disorders
Otitis media
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis / pneumonia
|
17.4%
4/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
17.4%
4/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Cardiac disorders
Atrial fibrillation
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
4.3%
1/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
17.4%
4/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis, basal cell carcinoma
|
13.0%
3/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
21.7%
5/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.7%
5/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Reproductive system and breast disorders
Increase in prostate specific antigen
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Reproductive system and breast disorders
Prostate nodule
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Eye disorders
Cataracts
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
13.0%
3/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
General disorders
Fatigue
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
4.3%
1/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
4.3%
1/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Reproductive system and breast disorders
Groin pain
|
8.7%
2/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
13.0%
3/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
13.0%
3/23 • 19 months.
Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place