Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer

• Sponsor: Veru Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03646162
• Collaborator: (none)
• Enrollment: 93
• Locations: 24
• Arms: 3
• Actual Duration (Months): 25
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Randomized, double-blind, placebo controlled, dose finding Phase 2 study comparing oral daily dosing of VERU-944 after a week of loading (daily dosing) with placebo to ameliorate the vasomotor symptoms resulting from androgen deprivation therapy in men with advanced prostate cancer

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Metastatic	Drug: Veru-944; Drug: Placebo	Phase 2

Detailed Description

This study is a multicenter, randomized, double-blind, placebo controlled, dose finding study of VERU-944 to treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT. The study will have four arms with 30 subjects per arm. The subjects participating in the study will have advanced prostate cancer and will be undergoing androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone (LHRH) therapy (agonist or antagonist) for at least the three months prior to randomization and be experiencing regular moderate to severe hot flashes while on ADT. Subjects will all continue to receive ADT and will be randomized to receive, for the first four days, a loading dose followed by daily doses of placebo or VERU-944 (10 mg, 50 mg or 100 mg) orally for a total period of 12 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-blind, Placebo Controlled, Dose Finding Phase 2 Study Comparing Oral Daily Dosing of VERU-944 to Ameliorate the Vasomotor Symptoms Resulting From ADT in Men With Advanced Prostate Cancer
• Actual Study Start Date: Sep 14, 2018
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: Oct 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Veru-944 10 mg Veru-944 10 mg daily	Drug: Veru-944; Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT; Other Names: Zuclomiphene citrate
Experimental: Veru-944 50 mg Veru-944 50 mg daily	Drug: Veru-944; Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT; Other Names: Zuclomiphene citrate
Placebo Comparator: Placebo Placebo daily	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Change in Frequency of Moderate to Severe Hot Flashes at 6 Weeks [6 weeks]

   Percentage of change in frequency of moderate to severe hot flashes at 6 weeks

Secondary Outcome Measures

1. Percentage Change in Severity of Moderate to Severe Hot Flashes at 6 Weeks [6 weeks]

   Change in severity of moderate to severe hot flashes compared to baseline at 6 weeks

2. Change of Frequency of Moderate to Severe Hot Flashes at Week 12 [Weeks 12]

   Mean change in frequency of moderate to severe hot flashes compared to baseline at weeks 12

3. Change in Severity of Moderate to Severe Hot Flashes at Week 12 [Week 12]

   Mean change in severity of moderate to severe hot flashes compared to baseline at week 12

4. Change in Bone Turnover Markers C-telopeptide (CTX) [84 days]

   Change in C-telopeptide concentration at day 84 compared to baseline

5. Change in Bone Turnover Markers Alkaline Phosphatase [84 days]

   Change in bone specific alkaline phosphatase at day 84 compared to baseline

Other Outcome Measures

1. Change in Serum PSA [84 Days]

   Change in serum PSA concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group

2. Change in Serum Total Testosterone [84 Days]

   Change in serum total testosterone concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group

3. Change in Serum Free Testosterone [84 days]

   Change in serum free testosterone concentration comparing baseline to day 84

4. Change in Serum SHBG [84 days]

   Change in serum SHBG concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group

5. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)Sess Safety [114 days]

   Incidence of Treatment-Emergent Adverse Events will be tabulated by MedDRA terms and system organ class. The incidence of AEs and the maximum intensity and frequency of AEs will be summarized. The intensity of AE will be graded according to CTCAE version 4. Changes from baseline will be computed and tested for significant change from baseline to day 114

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Be over 18 years of age;

2. Be able to communicate effectively with the study personnel;

3. Have histologically confirmed prostate cancer;

4. Have been treated with an LHRH agonist or LHRH antagonist for at least the 3 months prior to randomization;

5. Be continued on an LHRH agonist or LHRH antagonist throughout this study;

6. Have experienced hot flashes for at least one month prior to study entry;

7. Have moderate or severe vasomotor symptoms (hot flashes) (defined as a minimum of 4 moderate to severe hot flashes per day or 12 per week at baseline);

8. ECOG performance status of 0 to 2

9. Be willing to uses electronic data capture for the relevant medical events

• Must be at least 80% compliant during the screening period

1. Subjects must agree to use acceptable methods of contraception:

• If their female partners are pregnant or lactating, acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication must be used. Acceptable methods are: Condom used with spermicidal foam/gel/film/cream/suppository. If the subject has undergone surgical sterilization (vasectomy with documentation of azospermia), a condom with spermicidal foam/gel/film/cream/suppository should be used.

• If the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository).

• If the female partner has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used.

• If the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used.

1. Subject is willing to comply with the requirements of the protocol through the end of the study.

Exclusion Criteria

1. Have a serum total testosterone concentration > 50 ng/dL at screening;

2. Known hypersensitivity or allergy to estrogen or estrogen like drugs;

3. Any disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk;

4. Subjects with a personal history of abnormal blood clotting or thrombotic disease, including venous or arterial thrombotic events such as a history of stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE);

5. Any subjects, as determined by a central laboratory, that have a:

• Factor V Leiden gene mutation

• Prothrombin gene mutation

1. Uncontrolled symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia, or uncontrolled atrial fibrillation;

2. History of MI

3. The presence of consistently abnormal laboratory values which are considered clinically significant. In addition, any subject with liver enzymes (ALT or AST) above 2 times the upper limit of normal, total bilirubin above 2 times the upper limit of normal, or serum creatinine above 1.5 times the upper limit of normal will NOT be admitted to the study;

4. Received an investigational drug within a period of 90 days prior to enrollment in the study;

5. Received the study medication (VERU-944) previously;

6. Have previously taken within 6 months prior to screening or are currently taking diethylstilbestrol, other estrogens;

7. Currently taking gabapentin, estrogen, diethylstilbestrol, medroxyprogesterone acetate, clomiphene, selective serotonin reuptake inhibitors (SSRIs), other treatments for hot flashes

8. Recent hospitalization for more than 24 hours (within 30 days of screening);

9. Recent surgery (within 30 days of screening);

10. Have been previously diagnosed or treated for active cancer (other than prostate cancer or non-melanoma skin cancer) within the previous five years;

11. Have a BMI >40.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gen1 Research	Glendale	Arizona	United States	85308
2	Tower Urology	Los Angeles	California	United States	90048
3	Urology of San Bernardino	San Bernardino	California	United States	92404
4	The Urology Center of Colorado	Denver	Colorado	United States	80211
5	Foothills Urology	Golden	Colorado	United States	80401
6	Universal Axon Clinical Research	Doral	Florida	United States	33166
7	Medical Research Center	Miami	Florida	United States	33144
8	North Idaho Urology	Coeur d'Alene	Idaho	United States	83814
9	First Urology	Jeffersonville	Indiana	United States	47130
10	Regional Urology LLC	Shreveport	Louisiana	United States	71101
11	Chesapeake Urology	Towson	Maryland	United States	21204
12	Coastal Urology	Brick	New Jersey	United States	08724
13	Premier Urology Group	Edison	New Jersey	United States	08837
14	Advance Urology	Elmont	New York	United States	11003
15	AccuMed Research	Garden City	New York	United States	11530
16	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York	United States	12601
17	Associated Medical Professionals	Syracuse	New York	United States	13210
18	Clinical Research Solutions	Middleburg Heights	Ohio	United States	44130
19	Urologic Consultants	Bala-Cynwyd	Pennsylvania	United States	19004
20	Mary Crowley Cancer Research	Dallas	Texas	United States	75230
21	Urology Clinics of North Texas	Dallas	Texas	United States	75231
22	Houston Urology Partners	Houston	Texas	United States	77091
23	Urology San Antonio	San Antonio	Texas	United States	78229
24	Urology of Virginia	Virginia Beach	Virginia	United States	23462

Sponsors and Collaborators

• Veru Inc.

Investigators

• Study Chair: Barnette, Veru Inc.

Study Documents (Full-Text)

• Study Protocol - Jul 9, 2018
• Statistical Analysis Plan - Oct 30, 2019

More Information

Publications

None provided.

• Responsible Party: Veru Inc.
• ClinicalTrials.gov Identifier: NCT03646162
• Other Study ID Numbers: V72203
• First Posted: Aug 24, 2018
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 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
• Additional relevant MeSH terms: Prostatic Neoplasms; Zuclomiphene

Study Results

Participant Flow

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo
Period Title: Overall Study
STARTED	31	31	31
COMPLETED	26	27	30
NOT COMPLETED	5	4	1

Baseline Characteristics

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo	Total
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo	Total of all reporting groups
Overall Participants	30	30	31	91
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	4 13.3%	7 23.3%	9 29%	20 22%
>=65 years	26 86.7%	23 76.7%	22 71%	71 78%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.8 (5.79)	70.6 (8.84)	69.1 (8.05)	70.2 (7.50)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	30 100%	30 100%	31 100%	91 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	12 40%	9 30%	10 32.3%	31 34.1%
White	18 60%	20 66.7%	21 67.7%	59 64.8%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 3.3%	0 0%	1 1.1%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	31 100%	91 100%
Moderate to Severe Hot Flashes (Percentage hot flashes moderate severe) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage hot flashes moderate severe]	41.5 (36.52)	29.7 (22.2)	33.7 (20.23)	34.9 (26.25)

Outcome Measures

1. Primary Outcome

Title	Change in Frequency of Moderate to Severe Hot Flashes at 6 Weeks
Description	Percentage of change in frequency of moderate to severe hot flashes at 6 weeks
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Percentage of change in frequency of moderate to severe hot flashes at week 6

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo
Measure Participants	26	27	30
Mean (Standard Deviation) [Percentage of change in frequency]	-19.72 (8.840)	-42.24 (8.196)	-46.59 (7.760)

2. Secondary Outcome

Title	Percentage Change in Severity of Moderate to Severe Hot Flashes at 6 Weeks
Description	Change in severity of moderate to severe hot flashes compared to baseline at 6 weeks
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Percentage change in severity of moderate to severe hot flashes compared to baseline at 6 weeks

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo
Measure Participants	23	25	27
Mean (Standard Deviation) [percentage of change]	-0.21 (0.386)	-0.31 (0.416)	-0.35 (0.508)

3. Secondary Outcome

Title	Change of Frequency of Moderate to Severe Hot Flashes at Week 12
Description	Mean change in frequency of moderate to severe hot flashes compared to baseline at weeks 12
Time Frame	Weeks 12

Outcome Measure Data

Analysis Population Description

Percentage of change from Baseline to Week 12

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo
Measure Participants	26	27	30
Mean (Standard Error) [percentage of change]	-39.94 (8.458)	-51.95 (8.574)	-52.70 (7.881)

4. Secondary Outcome

Title	Change in Severity of Moderate to Severe Hot Flashes at Week 12
Description	Mean change in severity of moderate to severe hot flashes compared to baseline at week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Mean percentage change from baseline to week 12

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo
Measure Participants	26	27	30
Mean (Standard Error) [percentage of change]	-12.05 (5.014)	-16.93 (5.061)	-22.48 (4.674)

5. Secondary Outcome

Title	Change in Bone Turnover Markers C-telopeptide (CTX)
Description	Change in C-telopeptide concentration at day 84 compared to baseline
Time Frame	84 days

Outcome Measure Data

Analysis Population Description

Change in C-telopeptide concentration at day 84 compared to baseline

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo
Measure Participants	27	30	31
Mean (Standard Deviation) [ng/L]	419.7 (262)	362.1 (305.44)	466 (347.3)

6. Secondary Outcome

Title	Change in Bone Turnover Markers Alkaline Phosphatase
Description	Change in bone specific alkaline phosphatase at day 84 compared to baseline
Time Frame	84 days

Outcome Measure Data

Analysis Population Description

Change in bone specific alkaline phosphatase at day 84 compared to baseline

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo
Measure Participants	28	30	31
Mean (Standard Deviation) [ug/L]	13.89 (4.598)	15.72 (22.468)	13.12 (6.074)

7. Other Pre-specified Outcome

Title	Change in Serum PSA
Description	Change in serum PSA concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group
Time Frame	84 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Change in Serum Total Testosterone
Description	Change in serum total testosterone concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group
Time Frame	84 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Change in Serum Free Testosterone
Description	Change in serum free testosterone concentration comparing baseline to day 84
Time Frame	84 days

Outcome Measure Data

Analysis Population Description

Change in serum free testosterone concentration comparing baseline to day 84

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo
Measure Participants	29	30	29
Mean (Standard Deviation) [ng/L]	1.16 (0.895)	1.38 (4.873)	1.0 (1.635)

10. Other Pre-specified Outcome

Title	Change in Serum SHBG
Description	Change in serum SHBG concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group
Time Frame	84 days

Outcome Measure Data

Analysis Population Description

Change in serum SHBG concentration comparing baseline to day 84

Arm/Group Title	Veru-944 10 mg	Veru-944 50 mg	Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT	Placebo daily Placebo: Placebo
Measure Participants	29	30	30
Mean (Standard Deviation) [nmol/L]	55.7 (28.27)	113.5 (60.53)	54.1 (24.98)

11. Other Pre-specified Outcome

Title	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)Sess Safety
Description	Incidence of Treatment-Emergent Adverse Events will be tabulated by MedDRA terms and system organ class. The incidence of AEs and the maximum intensity and frequency of AEs will be summarized. The intensity of AE will be graded according to CTCAE version 4. Changes from baseline will be computed and tested for significant change from baseline to day 114
Time Frame	114 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Post-Hoc Outcome

Title	Post-hoc Analysis on the Percentage Change in Frequency of Moderate and Severe Hot Flashes From Baseline to Week 12; Exposure Response Assessment
Description	Post-hoc exploratory MMRM analysis was conducted to explore the effect of trough plasma concentration at Week12 on the change in frequency of moderate and severe hot flashes from Baseline to Week 12 in subjects with a BMI >25 kg/m2.
Time Frame	Day 84

Outcome Measure Data

Analysis Population Description

Subjects with a BMI >25 kg/m2 who had trough plasma concentrations ≥195 ng/mL vs <195 ng/mL Change in moderate and severe hot flash frequency at Week 12

Arm/Group Title	PK ≥195ng/mL	PK <195 ng/mL
Arm/Group Description	Subjects who had trough plasma concentrations ≥195 ng/mL at Day 84 change in moderate and severe hot flash frequency at Week 12,	Subjects who had trough plasma concentrations <195 ng/mL at Day 84 change in moderate and severe hot flash frequency at Week 12,
Measure Participants	9	56
Mean (Standard Deviation) [percentage of change]	-77.60 (14.542)	-50.14 (5.842)

Adverse Events

Time Frame	15 months
Arm/Group Title	Veru-944 10 mg		Veru-944 50 mg		Placebo
Arm/Group Description	Veru-944 10 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT		Veru-944 50 mg daily Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT		Placebo daily Placebo: Placebo
All Cause Mortality
	Veru-944 10 mg		Veru-944 50 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/31 (0%)
Serious Adverse Events
	Veru-944 10 mg		Veru-944 50 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		1/30 (3.3%)		2/31 (6.5%)
Cardiac disorders
Atrial Fibrillation	0/30 (0%)		0/30 (0%)		1/31 (3.2%)
Coronary Artery Disease	0/30 (0%)		0/30 (0%)		1/31 (3.2%)
Infections and infestations
Appendicitis	0/30 (0%)		1/30 (3.3%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Veru-944 10 mg		Veru-944 50 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/30 (23.3%)		16/30 (53.3%)		11/31 (35.5%)
Blood and lymphatic system disorders
Anaemia	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Neutropenia	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Atrial Fibrillation	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Cardiac disorders
Coronary artery disease	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Eye disorders
Vision Blurred	1/30 (3.3%)	1	1/30 (3.3%)	1	0/31 (0%)	0
Gastrointestinal disorders
Constipation	1/30 (3.3%)	1	1/30 (3.3%)	1	0/31 (0%)	0
Dyspepsia	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Flatulence	1/30 (3.3%)	1	1/30 (3.3%)	1	0/31 (0%)	0
Nauseas	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Abdominal Pain	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Abdominal Pain Upper	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Diarrhoea	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Gastroesophageal Reflux Disease	1/30 (3.3%)	1	0/30 (0%)	0	0/31 (0%)	0
General disorders
Fatigue	0/30 (0%)	0	1/30 (3.3%)	1	3/31 (9.7%)	3
Oedema Peripheral	1/30 (3.3%)	1	0/30 (0%)	0	0/31 (0%)	0
Pain	1/30 (3.3%)	1	0/30 (0%)	0	0/31 (0%)	0
Peripheral Swelling	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Infections and infestations
Urinary Tract Infection	0/30 (0%)	0	3/30 (10%)	3	0/31 (0%)	0
Nasopharyngitis	2/30 (6.7%)	2	0/30 (0%)	0	0/31 (0%)	0
Appendicitis	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Influenza	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Pneumonia	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Sinusitis	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Tooth Infection	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Upper Respiratory Tract Infection	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Injury, poisoning and procedural complications
Fall	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Investigations
Cardiac Murmur	1/30 (3.3%)	1	0/30 (0%)	0	0/31 (0%)	0
Low density lipoprotein increased	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/30 (3.3%)	1	0/30 (0%)	0	1/31 (3.2%)	1
Muscle Spasms	0/30 (0%)	0	1/30 (3.3%)	1	1/31 (3.2%)	1
Arthritis	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Back Pain	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Myalgia	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Pain in extremity	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Nervous system disorders
Headache	1/30 (3.3%)	1	1/30 (3.3%)	1	1/31 (3.2%)	1
Balance Disorder	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Burning sensation	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Disturbance in Attention	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Dizziness	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Memory Impairment	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Psychiatric disorders
Insomnia	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Renal and urinary disorders
Hematuria	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Micturition urgency	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Nephrolithiasis	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Nocturia	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Post micturition dribble	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Renal Mass	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/30 (0%)	0	1/30 (3.3%)	1	0/31 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	0/30 (0%)	0	0/30 (0%)	0	1/31 (3.2%)	1
Vascular disorders
Hypertension	0/30 (0%)	0	0/30 (0%)	0	2/31 (6.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.