Soy Protein/Effexor Hormone Therapy for Prostate Cancer

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00354432
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 120
• Locations: 20
• Arms: 4
• Actual Duration (Months): 42
• Patients Per Site: 6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes.

PURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Hot Flashes; Prostate Cancer	Dietary Supplement: oral soy protein/isoflavones powder; Drug: Venlafaxine; Dietary Supplement: Placebo Powder; Drug: Placebo Pill	Phase 3

Detailed Description

OBJECTIVES:

Primary

• Assess the effect of soy protein/isoflavones and venlafaxine on the hot flash symptom severity score in patients undergoing hormonal manipulation for treatment of prostate cancer.

Secondary

• Assess the effect of soy protein/isoflavones and venlafaxine on quality of life of these patients.

• Monitor and assess the participant drop out rate.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to severity of disease (metastatic vs nonmetastatic) and baseline severity of hot flashes. Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.

• Arm II: Patients receive oral venlafaxine and oral placebo powder once daily.

• Arm III: Patients receive oral venlafaxine and oral soy protein/isoflavones powder once daily.

• Arm IV: Patients receive oral placebo pill and oral placebo powder once daily. Treatment in all arms continues for 12 weeks in the absence of disease progression or unacceptable toxicity. After 12 weeks of treatment, patients in arms I and III receive a tapered dose of oral venlafaxine once daily for 1 week.

Patients complete a vasomotor symptom diary once daily beginning 7 days before the initiation of study treatment and continuing until the completion of study treatment. Quality of life is assessed at baseline and at week 12.

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
• Actual Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I - Placebo Patients receive oral placebo pill and oral placebo powder once daily.	Dietary Supplement: Placebo Powder; Placebo powder (20gm casein protein) orally 0 mg of total isoflavones; Other Names: Casein ; Drug: Placebo Pill; Patients receive oral placebo pill.; Other Names: Sugar Pill
Active Comparator: Arm II - Soy Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.	Dietary Supplement: oral soy protein/isoflavones powder; Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein; Other Names: Protein powder Supplement powder soy and casein 20gm Isoflavones Isocaloric supplement Casein protein ; Drug: Placebo Pill; Patients receive oral placebo pill.; Other Names: Sugar Pill
Experimental: Arm III - Venlafaxine Patients receive oral Venlafaxine pill and placebo powder once daily.	Drug: Venlafaxine; Patients receive oral venlafaxine 75mg.; Other Names: Effexor XR placebo ; Dietary Supplement: Placebo Powder; Placebo powder (20gm casein protein) orally 0 mg of total isoflavones; Other Names: Casein
Placebo Comparator: Arm IV - Soy + Venlafaxine Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.	Dietary Supplement: oral soy protein/isoflavones powder; Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein; Other Names: Protein powder Supplement powder soy and casein 20gm Isoflavones Isocaloric supplement Casein protein ; Drug: Venlafaxine; Patients receive oral venlafaxine 75mg.; Other Names: Effexor XR placebo

Outcome Measures

Primary Outcome Measures

1. Hot Flash Symptom Severity Score [12 weeks]

   The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.

Secondary Outcome Measures

1. Quality of Life [12 weeks]

   Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologic documentation of prostate cancer, any stage Life expectancy of > nine months

• Prior or current androgen deprivation for treatment or control of prostate cancer to include:

• Bilateral Orchiectomy

• LHRH agonist (with or without antiandrogen therapy) ie: leuprolide (Lupron), goserelin (Zoladex), bicalutamide (Casodex), flutamide (Eulexin), or similar agents

• Chemotherapy

• Radiation (Patients may undergo concurrent radiation therapy to the prostate, prostate

• seminal vesicles, and/or pelvis). Seed implants are allowed

• Participant report of hot flash frequency of an average of four or more per day, as defined by sweating, flushing, sensation of warmth, night sweats (Average of 28 per week)

• Hot flashes must be moderate or severe (See appendix A for hot flash definitions)

• Grade 2 (Moderate flashes) are warmer, produce obvious perspiration, and last 2 to 3 minutes

• Grade 3 (Severe flashes) causes profuse perspiration, generate intense heat, last longer and interfere with ongoing activity

• Age >21

• No allergies to soy or dairy products

• No current use of SSRIs, SNRI's, MAOIs, or Linezolide

• No uncontrolled hypertension (160/90) or greater than Class I American Heart Association functional capacity

• No history of mania, hypomania, bipolar disorder, or anorexia nervosa

• No history of seizures

• No history of hepatic dysfunction)

• Must have a telephone

• Signed protocol-specific Informed Consent

• Participants consuming soy foods or soy based supplements must continue on a stable regimen during study participation

• Patients should maintain same treatment and medications for prostate cancer throughout entire study.

• No change in treatment for 2 weeks prior to registration.

• Current use of medications and herbal supplements for hot flashes are allowed if on a stable regimen throughout the entire study. (Does not include anti-depressants)

Exclusion Criteria:

• Anticipated changes in prostate cancer treatment plan (i.e., hormonal manipulation, changes in chemotherapy)

• Concurrent antidepressant therapy

• History of intolerance to venlafaxine

• Recent (within 14 days) use of venlafaxine (Effexor XRTM), monoamine oxidase inhibitor, SSRI (selective serotonin reuptake inhibitor), or SNRI (selective norepinephrine reuptake inhibitor)

• History of seizure disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
2	MBCCOP - JHS Hospital of Cook County	Chicago	Illinois	United States	60612
3	CCOP - Central Illinois	Decatur	Illinois	United States	62526
4	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
5	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403
6	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
7	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
8	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
9	CCOP - Beaumont	Royal Oak	Michigan	United States	48073-6769
10	CCOP - Heartland Research Consortium	Saint Louis	Missouri	United States	63131
11	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
12	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65804
13	Alamance Cancer Center at Alamance Regional Medical Center	Burlington	North Carolina	United States	27216
14	Southeastern Medical Oncology Center - Goldsboro	Goldsboro	North Carolina	United States	27534
15	Caldwell Memorial Hospital	Lenoir	North Carolina	United States	28645
16	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
17	Wake Forest University CCOP Research Base	Winston-Salem	North Carolina	United States	27157
18	Cancer Centers of the Carolinas - Easley	Greenville	South Carolina	United States	29615
19	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
20	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54301

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Cancer Institute (NCI)

Investigators

• Study Chair: Mara Vitolins, DrPH, RD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00354432
• Other Study ID Numbers: REBAcccwfu97405; U10CA081851
• First Posted: Jul 20, 2006
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer; hot flashes
• Additional relevant MeSH terms: Prostatic Neoplasms; Hot Flashes; Venlafaxine Hydrochloride; Caseins

Study Results

Participant Flow

Arm/Group Title	Arm I - Placebo	Arm II - Soy	Arm III - Venlafaxine	Arm IV - Soy + Venlafaxin
Arm/Group Description	Patients receive oral placebo pill and oral placebo powder once daily.	Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.	Patients receive oral venlafaxine pill and oral placebo powder once daily.	Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
Period Title: Overall Study
STARTED	30	30	30	30
COMPLETED	24	22	20	20
NOT COMPLETED	6	8	10	10

Baseline Characteristics

Arm/Group Title	Arm I - Placebo	Arm II - Soy	Arm III - Venlafaxine	Arm IV - Soy + Venlafaxine	Total
Arm/Group Description	Patients receive oral placebo pill and oral placebo powder once daily.	Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.	Patients receive oral venlafaxine pill and oral placebo powder once daily.	Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.	Total of all reporting groups
Overall Participants	30	30	30	30	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	11 36.7%	9 30%	12 40%	11 36.7%	43 35.8%
>=65 years	19 63.3%	21 70%	18 60%	19 63.3%	77 64.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.8 (8.8)	71.0 (8.2)	67.8 (9.9)	67.5 (9.1)	68.5 (9.0)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	30 100%	30 100%	30 100%	30 100%	120 100%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	30 100%	30 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	Hot Flash Symptom Severity Score
Description	The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

All randomized participants were analyzed in a repeated measures mixed model. This allowed inclusion of all study participants.

Arm/Group Title	Arm I - Placebo	Arm II - Soy	Arm III - Venlafaxine	Arm IV - Soy + Venlafaxine
Arm/Group Description	Patients receive oral placebo pill and oral placebo powder once daily.	Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.	Patients receive oral Venlafaxine pill and placebo powder once daily.	Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
Measure Participants	30	30	30	30
Least Squares Mean (Standard Error) [percent of baseline score]	52.3 (10.8)	77.2 (11.6)	68.9 (12.1)	73.8 (11.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I - Placebo, Arm II - Soy, Arm III - Venlafaxine, Arm IV - Soy + Venlafaxine
	Comments	The null hypothesis was that there was no difference in the hot flash severity score at 12 weeks.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	.3455
	Comments	This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.
	Method	Mixed Models Analysis
	Comments	A mixed effects repeated measures analysis of variance was used with the baseline means constrained to be equal in the four groups.

2. Secondary Outcome

Title	Quality of Life
Description	Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Participants with baseline and 12 week quality of life data.

Arm/Group Title	Arm I - Placebo	Arm II - Soy	Arm III - Venlafaxine	Arm IV - Soy + Venlafaxine
Arm/Group Description	Patients receive oral placebo pill and oral placebo powder once daily.	Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.	Patients receive oral Venlafaxine pill and placebo powder once daily.	Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
Measure Participants	21	21	18	17
Least Squares Mean (Standard Error) [units on a scale]	115.6 (2.4)	121.5 (2.5)	114.3 (2.7)	117.7 (2.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I - Placebo, Arm II - Soy, Arm III - Venlafaxine, Arm IV - Soy + Venlafaxine
	Comments	Null hypothesis was that there was no difference in quality of life between the four groups at 12 weeks.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2081
	Comments	This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Arm I - Placebo		Arm II - Soy		Arm III - Venlafaxine		Arm IV - Soy + Venlafaxine
Arm/Group Description	Patients receive oral placebo pill and oral placebo powder once daily.		Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.		Patients receive oral Venlafaxine pill and placebo powder once daily.		Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
All Cause Mortality
	Arm I - Placebo		Arm II - Soy		Arm III - Venlafaxine		Arm IV - Soy + Venlafaxine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I - Placebo		Arm II - Soy		Arm III - Venlafaxine		Arm IV - Soy + Venlafaxine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/30 (13.3%)		5/27 (18.5%)		5/29 (17.2%)		5/28 (17.9%)
General disorders
Fatigue	1/30 (3.3%)	1	0/27 (0%)	0	0/29 (0%)	0	0/28 (0%)	0
Insomnia	0/30 (0%)	0	0/27 (0%)	0	0/29 (0%)	0	1/28 (3.6%)	1
Mood alteration - Agitation	1/30 (3.3%)	1	0/27 (0%)	0	0/29 (0%)	0	0/28 (0%)	0
Pain - Other	2/30 (6.7%)	3	1/27 (3.7%)	1	1/29 (3.4%)	2	0/28 (0%)	0
Pain - chest NOS	0/30 (0%)	0	0/27 (0%)	0	0/29 (0%)	0	1/28 (3.6%)	3
Somnolence	0/30 (0%)	0	0/27 (0%)	0	1/29 (3.4%)	1	0/28 (0%)	0
Infections and infestations
Infection - Rectum	0/30 (0%)	0	0/27 (0%)	0	1/29 (3.4%)	1	0/28 (0%)	0
Musculoskeletal and connective tissue disorders
Pain - joint	1/30 (3.3%)	1	0/27 (0%)	0	0/29 (0%)	0	0/28 (0%)	0
Nervous system disorders
Mood alteration- Anxiety	1/30 (3.3%)	1	0/27 (0%)	0	0/29 (0%)	0	0/28 (0%)	0
Renal and urinary disorders
Obstruction - Ureter	1/30 (3.3%)	1	0/27 (0%)	0	0/29 (0%)	0	0/28 (0%)	0
Reproductive system and breast disorders
Erectile Dysfunction	2/30 (6.7%)	6	4/27 (14.8%)	13	2/29 (6.9%)	8	4/28 (14.3%)	13
Vascular disorders
Vascular - other	0/30 (0%)	0	0/27 (0%)	0	0/29 (0%)	0	1/28 (3.6%)	3
Other (Not Including Serious) Adverse Events
	Arm I - Placebo		Arm II - Soy		Arm III - Venlafaxine		Arm IV - Soy + Venlafaxine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/30 (93.3%)		23/27 (85.2%)		29/29 (100%)		27/28 (96.4%)
Ear and labyrinth disorders
Dizziness	6/30 (20%)	12	5/27 (18.5%)	11	7/29 (24.1%)	9	5/28 (17.9%)	9
Gastrointestinal disorders
Constipation	12/30 (40%)	23	5/27 (18.5%)	11	6/29 (20.7%)	15	10/28 (35.7%)	29
Diarrhea - without colostomy	6/30 (20%)	7	3/27 (11.1%)	3	5/29 (17.2%)	12	3/28 (10.7%)	7
Distension/Bloating, Abdominal	6/30 (20%)	11	7/27 (25.9%)	14	10/29 (34.5%)	15	6/28 (21.4%)	12
Dry Mouth	10/30 (33.3%)	28	6/27 (22.2%)	16	7/29 (24.1%)	10	7/28 (25%)	22
Flatulence	11/30 (36.7%)	22	9/27 (33.3%)	21	9/29 (31%)	17	11/28 (39.3%)	27
Nausea	6/30 (20%)	9	3/27 (11.1%)	8	5/29 (17.2%)	6	8/28 (28.6%)	15
Vomiting	3/30 (10%)	3	0/27 (0%)	0	0/29 (0%)	0	0/28 (0%)	0
General disorders
Allergic Reaction/hypersensitivity including drug reaction	1/30 (3.3%)	2	1/27 (3.7%)	4	2/29 (6.9%)	2	0/28 (0%)	0
Anorexia	4/30 (13.3%)	8	0/27 (0%)	0	3/29 (10.3%)	4	5/28 (17.9%)	12
Constitutional Symptioms - Nightmares	2/30 (6.7%)	3	1/27 (3.7%)	1	2/29 (6.9%)	5	3/28 (10.7%)	9
Fatigue	18/30 (60%)	47	11/27 (40.7%)	36	18/29 (62.1%)	35	15/28 (53.6%)	36
Insomnia	15/30 (50%)	45	8/27 (29.6%)	20	11/29 (37.9%)	26	11/28 (39.3%)	26
Pain - Other	15/30 (50%)	38	13/27 (48.1%)	43	11/29 (37.9%)	32	8/28 (28.6%)	19
Pain - Back	0/30 (0%)	0	1/27 (3.7%)	4	2/29 (6.9%)	2	0/28 (0%)	0
Pain - Extremity - Limb	0/30 (0%)	0	0/27 (0%)	0	0/29 (0%)	0	2/28 (7.1%)	2
Sweating - Diaphoresis	20/30 (66.7%)	61	20/27 (74.1%)	64	24/29 (82.8%)	63	25/28 (89.3%)	74
Musculoskeletal and connective tissue disorders
Pain - joint	2/30 (6.7%)	4	1/27 (3.7%)	1	0/29 (0%)	0	2/28 (7.1%)	3
Nervous system disorders
Confusion	3/30 (10%)	3	0/27 (0%)	0	2/29 (6.9%)	3	2/28 (7.1%)	2
Neurology - Nervousness	3/30 (10%)	6	0/27 (0%)	0	1/29 (3.4%)	1	3/28 (10.7%)	7
Neuropathy - Sensory	2/30 (6.7%)	7	0/27 (0%)	0	1/29 (3.4%)	1	0/28 (0%)	0
Psychiatric disorders
Mood Alteration - Agitation	3/30 (10%)	5	5/27 (18.5%)	10	7/29 (24.1%)	10	8/28 (28.6%)	12
Mood Alteration - Anxiety	3/30 (10%)	10	4/27 (14.8%)	10	6/29 (20.7%)	11	3/28 (10.7%)	6
Somnolence	0/30 (0%)	0	1/27 (3.7%)	1	1/29 (3.4%)	1	4/28 (14.3%)	7
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)	0/30 (0%)	0	0/27 (0%)	0	2/29 (6.9%)	5	0/28 (0%)	0
Urinary Frequency/Urgency	2/30 (6.7%)	5	1/27 (3.7%)	4	2/29 (6.9%)	5	3/28 (10.7%)	8
Reproductive system and breast disorders
Ejaculatory Dysfunction	17/30 (56.7%)	58	11/27 (40.7%)	36	13/29 (44.8%)	39	12/28 (42.9%)	36
Erectile Dysfunction	17/30 (56.7%)	62	12/27 (44.4%)	42	13/29 (44.8%)	37	12/28 (42.9%)	32
Skin and subcutaneous tissue disorders
Petechiae/purpura - hemorrhage/bleeding into skin or mucosa	1/30 (3.3%)	4	2/27 (7.4%)	6	0/29 (0%)	0	1/28 (3.6%)	3
Vascular disorders
Hypertension	4/30 (13.3%)	8	8/27 (29.6%)	17	4/29 (13.8%)	8	3/28 (10.7%)	8

Limitations/Caveats

The study was stopped early by the DSMB due to a lack of effect.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.