Trial Outcomes & Findings for L-Arginine Supplementation With or Without Enzyme Inhibitors Treating Erectile Function of Prostate Cancer Survivors (NCT NCT01105130)

Last Updated: 2021-09-28

Results Overview

The International Index of Erectile Function (IIEF) questionnaire consists of 15 questions, each of which is scored on a 0 to 5 or 1 to 5 scale. It is comprised of five domains, each scored as the sum of 2 to 5 questions. Erectile function is the sum of six questions with a range from 1 to 30. Higher scores indicate better functioning.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

140 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I - Placebo Patients receive oral placebo twice daily (total of 6 capsules per day). Placebo: Given orally	Arm II - Low Dose Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Placebo: Given orally Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules	Arm III - High Dose Oral L-arginine twice daily = 6 capsules per day. Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily
Overall Study STARTED	48	45	47
Overall Study COMPLETED	38	34	37
Overall Study NOT COMPLETED	10	11	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I - Placebo Patients receive oral placebo twice daily (total of 6 capsules per day). Placebo: Given orally	Arm II - Low Dose Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Placebo: Given orally Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules	Arm III - High Dose Oral L-arginine twice daily = 6 capsules per day. Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily
Overall Study Withdrawal by Subject	4	6	2
Overall Study Never Started	2	2	4
Overall Study Toxicity	1	3	2
Overall Study Multiple Reasons	3	0	2

Baseline Characteristics

L-Arginine Supplementation With or Without Enzyme Inhibitors Treating Erectile Function of Prostate Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I - Placebo n=48 Participants Patients receive oral placebo twice daily (total of 6 capsules per day). Placebo: Given orally	Arm II - Low Dose n=45 Participants Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Placebo: Given orally Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules	Arm III - High Dose n=47 Participants Oral L-arginine twice daily = 6 capsules per day. Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants	13 Participants n=107 Participants	13 Participants n=206 Participants	40 Participants n=7 Participants
Age, Categorical >=65 years	34 Participants n=99 Participants	32 Participants n=107 Participants	34 Participants n=206 Participants	100 Participants n=7 Participants
Age, Continuous	68 years n=99 Participants	68 years n=107 Participants	67 years n=206 Participants	68 years n=7 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Sex: Female, Male Male	48 Participants n=99 Participants	45 Participants n=107 Participants	47 Participants n=206 Participants	140 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=99 Participants	43 Participants n=107 Participants	45 Participants n=206 Participants	133 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	5 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	2 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	13 Participants n=99 Participants	17 Participants n=107 Participants	17 Participants n=206 Participants	47 Participants n=7 Participants
Race (NIH/OMB) White	35 Participants n=99 Participants	28 Participants n=107 Participants	28 Participants n=206 Participants	91 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment United States	48 participants n=99 Participants	45 participants n=107 Participants	47 participants n=206 Participants	140 participants n=7 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All participants providing data at any time.

Outcome measures

Outcome measures
Measure	Arm I - Placebo n=46 Participants Patients receive oral placebo twice daily (total of 6 capsules per day). Placebo: Given orally	Arm II - Low Dose n=43 Participants Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Placebo: Given orally Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules	Arm III - High Dose n=46 Participants Oral L-arginine twice daily = 6 capsules per day. Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily
International Index of Erectile Function (IIEF)	14.62 units on a scale Standard Error 1.09	14.26 units on a scale Standard Error 1.13	11.82 units on a scale Standard Error 1.11

SECONDARY outcome

Timeframe: 8 weeks

Population: All randomized participants

Retention is the percentage of participants who complete the 8 week visit.

Outcome measures

Outcome measures
Measure	Arm I - Placebo n=48 Participants Patients receive oral placebo twice daily (total of 6 capsules per day). Placebo: Given orally	Arm II - Low Dose n=45 Participants Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Placebo: Given orally Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules	Arm III - High Dose n=46 Participants Oral L-arginine twice daily = 6 capsules per day. Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily
Retention	79.2 percentage of participants Interval 65.0 to 89.5	75.6 percentage of participants Interval 60.5 to 87.1	78.7 percentage of participants Interval 64.3 to 89.3

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants who returned pill diaries.

Adherence is the percentage of prescribed pills taken by the participants

Outcome measures

Outcome measures
Measure	Arm I - Placebo n=42 Participants Patients receive oral placebo twice daily (total of 6 capsules per day). Placebo: Given orally	Arm II - Low Dose n=41 Participants Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Placebo: Given orally Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules	Arm III - High Dose n=40 Participants Oral L-arginine twice daily = 6 capsules per day. Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily
Adherence	96.5 percentage of prescribed pills Interval 40.0 to 100.0	95.0 percentage of prescribed pills Interval 50.0 to 100.0	95.0 percentage of prescribed pills Interval 36.0 to 100.0

SECONDARY outcome

Timeframe: 8 weeks

Population: All participants who completed the FACT\_P at any time.

Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate (FACT\_P) questionnaire. The FACT questionnaire is comprised of four subscales - social, emotional, functional, and physical. Each subscale is obtained by summing over 6-7 items, each of which is coded on a 0 to 4 scale. Negatively worded questions are reverse scored and higher scores for each subscale indicate better HRQOL. The social, functional, and physical subscales range from 0 to 28 while the emotional subscale ranges from 0 to 24. The overall score (FACT-G) is the sum over the four subscales and ranges from 0 to 108. Patients also completed 12 questions related to prostate cancer, and the prostate subscale score is the sum of those responses (with some items reverse scored). Scores range from 0 to 48, and as with the other FACT subscales higher scores indicate better HRQOL. FACT-P is the sum of FACT-G and the prostate subscale. This questionnaire was added half-way through the study.

Outcome measures

Outcome measures
Measure	Arm I - Placebo n=24 Participants Patients receive oral placebo twice daily (total of 6 capsules per day). Placebo: Given orally	Arm II - Low Dose n=26 Participants Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Placebo: Given orally Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules	Arm III - High Dose n=27 Participants Oral L-arginine twice daily = 6 capsules per day. Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily
Assessment of Quality of Life	128.54 units on a scale Standard Error 3.11	128.67 units on a scale Standard Error 3.08	127.41 units on a scale Standard Error 3.15

Adverse Events

Arm I - Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Arm II - Low Dose

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Arm III - High Dose

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I - Placebo n=41 participants at risk Patients receive oral placebo twice daily (total of 6 capsules per day). Placebo: Given orally	Arm II - Low Dose n=42 participants at risk Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Placebo: Given orally Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules	Arm III - High Dose n=42 participants at risk Oral L-arginine twice daily = 6 capsules per day. Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily
Gastrointestinal disorders Vomiting	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Skin and subcutaneous tissue disorders Rash	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.

Other adverse events

Additional Information

Dr. Doug Case

Wake Forest NCORP Research Base

Phone: (336) 716-1048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I - Placebo n=41 participants at risk Patients receive oral placebo twice daily (total of 6 capsules per day). Placebo: Given orally	Arm II - Low Dose n=42 participants at risk Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Placebo: Given orally Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules	Arm III - High Dose n=42 participants at risk Oral L-arginine twice daily = 6 capsules per day. Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily
General disorders Agitation	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
General disorders Breast Pain	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Skin and subcutaneous tissue disorders Bruising	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Gastrointestinal disorders Constipation	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	4.8% 2/42 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Gastrointestinal disorders Diarrhea	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	4.8% 2/42 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Nervous system disorders Dizziness	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	4.8% 2/42 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Gastrointestinal disorders Dyspepsia	9.8% 4/41 • Number of events 4 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	7.1% 3/42 • Number of events 3 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.9% 2/41 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Reproductive system and breast disorders Ejaculation Disorder	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	4.8% 2/42 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Reproductive system and breast disorders Erectile Dysfunction	2.4% 1/41 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
General disorders Fatigue	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Gastrointestinal disorders Gastrointestional Disorder - Other	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
General disorders Headache	7.3% 3/41 • Number of events 3 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Renal and urinary disorders Hematuria	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
General disorders Hot Flashes	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Infections and infestations Infections and Infestations - Other	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Psychiatric disorders Insomnia	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Reproductive system and breast disorders Libido Increased	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Gastrointestinal disorders Nausea	4.9% 2/41 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	4.8% 2/42 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	4.8% 2/42 • Number of events 3 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
General disorders Pain	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Infections and infestations Penile Infection	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.4% 1/41 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Skin and subcutaneous tissue disorders Rash pustular	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorder - other	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Renal and urinary disorders urinary retention	0.00% 0/41 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	2.4% 1/42 • Number of events 2 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Skin and subcutaneous tissue disorders Urticaria	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.
Gastrointestinal disorders Vomiting	2.4% 1/41 • Number of events 1 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.	0.00% 0/42 • 8 weeks of treatment plus 4 weeks after treatment ends The sample size for this section was the number of participants in each arm who had post-randomization toxicity data recorded.