(231 days)
Not Found
Not Found
No
The device description and performance studies focus on a topical gel formulation and its physical effects, with no mention of AI or ML.
Yes
The device is clearly indicated for the "Treatment of erectile dysfunction," which is a medical condition, and its mechanism of action is described to stimulate blood flow and nerve endings for tumescence and erection, demonstrating a direct therapeutic effect on the body.
No
The device is described as a topical treatment for erectile dysfunction, not as a tool for diagnosing medical conditions. Its function is to stimulate blood flow and facilitate erection, not to assess or identify a condition. While a usability study mentions users self-diagnosing ED, the device itself doesn't perform diagnostic functions.
No
The device is described as a hydro-alcoholic gel formulation for topical application, supplied in single-dose aluminum tubes. This is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Treatment of erectile dysfunction." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a "non-medicated, hydro-alcoholic gel formulation for topical application to the glans penis." It works by stimulating blood flow through a physical cooling and warming effect. This is a physical mechanism of action for treatment, not a method for diagnosing a condition by examining samples from the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to test or analyze samples (like blood, urine, or tissue) to determine the presence or state of a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Treatment of erectile dysfunction in adult males aged 22 years and over.
Product codes (comma separated list FDA assigned to the subject device)
OWW
Device Description
Eroxon is a non-medicated, hydro-alcoholic gel formulation for topical application to the glans penis prior to sexual intercourse. Eroxon is intended as a topical treatment for male erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for satisfactory sexual performance.
Upon application, Eroxon stimulates blood flow through the penis. The volatile components of the formulation (alcohol, water) evaporate to create a rapid, localized cooling effect on the glans penis followed by a recovering slower warming effect. This stimulates nerve endings leading to tumescence and erection.
Eroxon is supplied in single-dose aluminum tubes. Each tube is designed to dispense approximately 300 mg of gel.
The device is supplied non-sterile and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glans penis
Indicated Patient Age Range
22 years and over.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility/Materials:
Eroxon is categorized as a surface device that contacts both the skin and mucosal membrane for a limited (), viscosity (USP), minimum fill (USP), osmolality (USP ), microbial quality (USP), antimicrobial effectiveness (USP ).
Results: Eroxon met acceptance criteria for all tests, demonstrating acceptable stability and functional performance over the 12-month shelf life.
Performance Testing - Bench:
- Condom Compatibility test: Demonstrated that the tensile or airburst properties of natural rubber latex, polyurethane and polyisoprene condom are not significantly affected by Eroxon in accordance with ASTMD7661-10. This testing supports the statement in the device labeling that Eroxon is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
- Device specification testing: Demonstrated that Eroxon can meet its specifications as described in Table 2.
- Temperature profiling test: Demonstrated that Eroxon can create a rapid cooling effect followed by a recovery warming effect under ex-vivo simulated use conditions.
Results: Eroxon performs as intended under anticipated conditions of use.
Usability Study:
Study type: Single-visit, single-site human factors validation testing.
Sample size: 32 users initially enrolled, 21 users completed the human factors portion.
Purpose: To evaluate if users were able to properly self-diagnose erectile dysfunction (ED), make a correct self-selection based on the device labeling, and correctly perform performance-based and knowledge-based tasks for safe and effective use without medical supervision.
Results: Nearly all users (97%) were able to correctly self-diagnose their ED. The study concluded that the likelihood of a user incorrectly self-diagnosing as an ED sufferer was inherently low. Performance and knowledge-based tasks demonstrated that risks were reduced to an acceptable level. Labeling is acceptable for over-the-counter use.
Clinical Study:
Study type: Multi-center, international, 2:1 randomized, open-label, home use, parallel group clinical investigation.
Duration: 24-weeks of treatment (study period up to 30 weeks including screening and follow-up).
Sample size: 96 patients randomized (48 to Eroxon, 48 to tadalafil 5 mg arm). 94 received treatment.
Data Source: Countries of Georgia (n=30), Poland (n=54), Bulgaria (n=3), and the US (n=9).
Primary Effectiveness Endpoints:
- Improvement compared to baseline of the erectile function (EF) domain of the International Index for Erectile Function (IIEF) in patients randomized to Eroxon, at 24 weeks post-randomization (mean change from baseline greater than zero).
- Mean change from baseline of the IIEF-EF in patients randomized to Eroxon, at 24 weeks post-randomization, greater than or equal to the minimally clinically important difference (MCID) of 4, as published by Rosen et al 2011.
Secondary Effectiveness Endpoints: - Mean percentage of Eroxon uses per patient that result in the patient noticing their erection starting within a certain period of time was greater than 30% during the 24-week treatment period.
- Mean percentage of Eroxon uses per patient that result in the ability to have penetrative sex within a certain period of time was greater than 30% during the 24-week treatment period.
Exploratory Endpoint (considered by FDA): - Proportion of patients reporting a meaningful improvement in the IIEF-EF domain according to the criteria published by Rosen et al 2011. assessed every 4-weeks postrandomization (evaluated by mild, moderate, and severe ED).
Safety Endpoints: Evaluated based on treatment emergent adverse events (TEAEs) and standard physical and laboratory assessments.
Analysis Population: Full analysis set for effectiveness (all randomized patients); Safety analysis set for safety (all randomized patients who used treatment at least once).
Results Summary:
Mean change in IIEF-EF from Baseline at Week 24 for Eroxon group: 5.73 (SE: 1.00), 95% CI: 3.767, 7.701. t-statistics: 5.71, One sided p-value: 4): 62%
Percentage of Eroxon uses resulting in erection by 10 minutes: 62.6%
Percentage of Eroxon uses resulting in penetrative sex within 15 minutes: 55.7%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR EROXON
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Non-medicated topical formulation for treatment of erectile dysfunction. A nonmedicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.
NEW REGULATION NUMBER: 21 CFR 876.5021
CLASSIFICATION: Class II
PRODUCT CODE: OWW
BACKGROUND
DEVICE NAME: Eroxon
SUBMISSION NUMBER: DEN220078
DATE DE NOVO RECEIVED: October 21, 2022
SPONSOR INFORMATION:
Future Medical Developments Limited 10 Holmes Court. Morristown, NJ 07960
INDICATIONS FOR USE
The Eroxon is indicated as follows:
Treatment of erectile dysfunction in adult males aged 22 years and over.
LIMITATIONS
Contraindications
- · Do not use the Eroxon if allergic to any of the product ingredients.
Warnings
- Stop using the Eroxon if any irritation (e.g., burning, itching or redness) is observed from . the use. If irritation continues, seek medical attention.
1
Precautions
- . The product should not be used by anyone under the age of 22.
- . This product should not be used if there is any disease or deformity of the penis.
- Do not use the product if the skin on the penis is red or sore or appears damaged or . broken.
- . Do not use the product if advised by the doctor to avoid sexual activity.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS AND PRECAUTIONS.
DEVICE DESCRIPTION
Eroxon is a non-medicated, hydro-alcoholic gel formulation for topical application to the glans penis prior to sexual intercourse. Eroxon is intended as a topical treatment for male erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for satisfactory sexual performance.
Upon application, Eroxon stimulates blood flow through the penis. The volatile components of the formulation (alcohol, water) evaporate to create a rapid, localized cooling effect on the glans penis followed by a recovering slower warming effect. This stimulates nerve endings leading to tumescence and erection.
Eroxon is supplied in single-dose aluminum tubes. Each tube is designed to dispense approximately 300 mg of gel.
The device is supplied non-sterile and is for single use only.
The device formulation for Eroxon and information on the ingredients in its formulation are provided in the Table 1:
| Ingredient | Description | Quantity
(%w/w) | Chemical
Grade | Supplier Name | Chemical
Abstract
Service (CAS)
Number |
|-------------------|----------------------|--------------------|-------------------|------------------------------|-------------------------------------------------|
| Alcohol | Volatile
compound | (b)(4) | USP | Berkel AHK | 64-17-5 |
| Purified
Water | Volatile
compound | | USP | In house ring main
system | 7732-18-5 |
Table 1: Device formulation and ingredient information
2
| Ingredient | Description | Quantity
(%w/w) | Chemical
Grade | Supplier Name | Chemical
Abstract
Service (CAS)
Number |
|-------------------------------------|--------------------------|--------------------|-------------------|--------------------------------------------------------|-------------------------------------------------|
| Glycerin | Non-volatile
compound | (b)(4) | USP | Cremer Oleo GmbH
& Co. KG | 56-81-5 |
| Propylene
glycol | Non-volatile
compound | | USP | Hedinger GmbH &
Co. KG | 57-55-6 |
| Carbomer
(Carbopol
Ultrez 10) | Viscosity
modifier | | NF | Lubrizol Advanced
Materials, Inc.
Europe B.V.B.A | 195739-91-4 |
| Potassium
hydroxide | pH modifier | | NF | Merck KGaA | 1310-58-3 |
The specifications for Eroxon are provided in Table 2.
| Test | Specification | Method |
|---|---|---|
| Appearance | Clear to turbid, colorless to | |
| off-white gel, free from | ||
| particulate matter | Visual | |
| Odor | Alcoholic odor | Organoleptic |
| Alcohol content (%) | (b)(4) | GC in-house method (GB1- |
| QA-PT-330) | ||
| pH | USP | |
| Viscosity (cP) | USP | |
| Minimum Fill | Conforms to USP | USP |
| Osmolality | ||
| (mOsm/kg) | (b)(4) | USP |
| Microbial Quality | USP | |
| Antimicrobial Effectiveness | Conforms to USP 51 for | |
| category 2 products | USP | |
| USP - United States Pharmacopeia | ||
| TAMC - Total aerobic microbial count | ||
| TYMC - Total yeasts/mold count | ||
| GC - Gas Chromatography |
3
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
Eroxon is categorized as a surface device that contacts both the skin and mucosal membrane for a limited (), viscosity (USP), minimum fill (USP), osmolality (USP ), microbial quality (USP), antimicrobial effectiveness (USP ) and weight change % on the samples. Following exposure to the real-time aging conditions, Eroxon met the acceptance criteria for each of the tests as described in Table 2. The results demonstrate that Eroxon has acceptable stability and functional performance over the duration of the 12month shelf life.
4
PERFORMANCE TESTING - BENCH
Eroxon underwent the following bench performance tests:
- . Condom Compatibility test: Demonstrated that the tensile or airburst properties of natural rubber latex, polyurethane and polyisoprene condom are not significantly affected by Eroxon in accordance with ASTMD7661-10. This testing supports the statement in the device labeling that Eroxon is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
- Device specification testing: Demonstrated that Eroxon can meet its specifications as . described in Table 2.
- Temperature profiling test: Demonstrated that Eroxon can create a rapid cooling effect . followed by a recovery warming effect under ex-vivo simulated use conditions.
The results of this testing demonstrate that Eroxon performs as intended under anticipated conditions of use.
SUMMARY OF CLINICAL INFORMATION
USABILITY STUDY
Human factors (HF) validation testing was conducted following the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices. The sponsor conducted a single-visit, single-site study with 32 users initially enrolled and 21 users completing the human factors portion of the study to evaluate if users were able to properly self-diagnose erectile dysfunction (ED), make a correct self-selection based on the device labeling, and correctly perform performance-based and knowledge-based tasks (based on the device labeling and instructions for use) necessary for the safe and effective use of the device in the absence of medical supervision.
Overall, nearly all users (97%) were able to correctly self-diagnose their ED. The single user who incorrectly self-diagnosed was judged by the sponsor as likely to have previous or episodic (not current) experience of ED. The study concluded that the likelihood of a user incorrectly selfdiagnosing as an ED sufferer was inherently low. Evaluation of the performance and knowledgebased tasks demonstrated that the risks associated with the use of Eroxon were reduced to an acceptable level. The results of this study supported that the labeling is acceptable for over-thecounter use.
CLINICAL STUDY
The sponsor conducted a pivotal study to support the safety and effectiveness of Eroxon for the treatment of erectile dysfunction.
The pivotal study was a multi-center, international, 2:1 randomized, open-label, home use, parallel group clinical investigation. The study was conducted over a period of 24-weeks.
De Novo Summary (DEN210078)
5
The patients were randomized into one of two treatment groups, the investigational group with application of Eroxon or the control group with oral intake of tadalafil 5mg tablets. (The use of tadalafil in the pivotal study was exploratory and was not used for safety and effectiveness comparison against Eroxon). Each patient could participate in the study for up to 9 study site visits within 30 weeks: up to 5 weeks of screening, 24 weeks of treatment, and 1 week of followup. The 24 weeks of treatment period was divided into six 4-week periods. The patients completed onset of action questions after the first intercourse attempt following each treatment and the International Index for Erectile Function (IIEF) and self-esteem and relationship questionnaire (SEAR) at the end each 4-week period. Patients and their female partners were monitored for adverse events through self-reported diaries for each 4-week use period and, monitoring symptoms as they experienced them.
The inclusion and exclusion criteria for the study are as follows:
Inclusion Criteria
-
- Males aged 22-70.
-
- Confirmed clinical diagnosis of ED for more than 3 months.
-
- Answered 'yes' to the question regarding the presence of residual Erectile Function (EF) over the past 3 months.
-
- Had been involved in a continuous heterosexual relationship at least 6 months prior to screening.
-
- Had documented written informed consent from both patient and his female partner.
-
- If the male patient's female partner was of childbearing potential from the time of first sexual intercourse attempt during the screening period until the last administration of investigational treatment, then the couple must have used a medically acceptable form of contraception for at least 3 months prior to entering the clinical investigation and agreed to continue such use for at least 1 month after the last administration of Eroxon or tadalafil (5 mg). Patients who were or wished to become pregnant were not included in the investigation.
-
- Patient and his female partner were capable of understanding and complying with the requirements of the clinical investigation plan and signed the informed consent form (ICF) prior to participation in any investigation-related procedures.
-
- Had Low International Index for Erectile Function- Erectile Function (IIEF-EF) scores (≤25) at the end of the screening period (i.e., Visit 2).
Exclusion Criteria
-
- Had any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological or psychiatric disease.
-
- Had any history of an unstable medical or psychiatric condition or used any medication that, in the opinion of the Investigator, was likely to affect the patient's ability to complete the investigation or precluded the patient's participation in the investigation.
-
- Had any presence of a symptomatic, active urinary tract infection diagnosed by the Investigator or their delegate at screening or during the investigation.
6
-
- Had a chronic indwelling urethral catheterization or penile anatomical abnormalities (e.g., penile fibrosis) that would significantly impair EF.
-
- Had a history of operations for Pevronie's disease.
-
- Had primary hypoactive sexual desire or any history of hypogonadism.
-
- Had a history of radical prostatectomy.
-
- Had a history of severe/uncontrolled diabetes.
-
- Were taking 2 or mor anti-hypertensives for the treatment of blood pressure.
-
- Had a hypersensitivity to any of the excipients.
-
- Had concomitant treatment with sildenafil citrate, vardenafil, and other PDE-5 inhibitors.
-
- Were taking alpha blockers, guanylate cyclase stimulators, such as riociguat, doxazocin, or any form of organic nitrate.
-
- Were receiving testosterone pellets.
-
- Had any penile surgery except circumcision.
-
- Had any treatment with acetyl cysteine within 6 months.
-
- Had any treatment with dihydroergotamine within 6 months.
-
- Had loss of vision in one eye because of non-arterior ischaemic optic neuropathy
-
- Had increased intracranial pressure (e.g., head trauma or cerebral haemorrhage) or inadequate cerebral circulation.
-
- Had a history of migraine or recurrent headache.
-
- Had aortic or mitral stenosis.
-
- Had hypertrophic obstructive cardiomyopathy.
-
- Had constrictive pericarditis or pericardial tamponade.
-
- Had closed-angle glaucoma.
-
- Had a nursing partner who was pregnant, or a partner who wished to become pregnant during the course of the investigation.
-
- Had confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, tricyclic antidepressants and methadone) or from the alcohol breath test at screening (for clarification, any positive result from the urine drug screen or alcohol breath tests at screening. If a patient was using medication which may have given a positive result. exclusion was at the PI's discretion.
-
- Had recent (in the last 12 months) clinical evidence of alcoholism or drug abuse.
-
- Had a positive screen for hepatitis B consisting of hepatitis B surface antigen hepatitis C antibody and human immunodeficiency virus.
-
- Had any clinically significant abnormal laboratory value, vital signs, or other safety findings as determined by medical history, physical examination, or other evaluations conducted at screening or on admission.
-
- Were unwilling to cease use of vacuum devices, intracavernosal injections. PDE-5s, or other non-clinical investigation therapies for ED for the entire course of the investigation.
-
- Patient or their partner were unwilling to agree to make the required attempts at sexual intercourse during the treatment period.
-
- Had a history of unresponsiveness to PDE-5 treatment or significant side effects, exclusion visual disturbances, with PDE-5s.
-
- Had fewer than 4 attempts at sexual intercourse during the screening period.
-
- Patient or their partner were illiterate or were unable to understand the language in which the questionnaires are available.
7
-
- Had received an investigational product during the 90 days prior to dosing for this investigation.
-
- Patient or his partner could not communicate reliably with the Investigator.
-
- Has severe premature ejaculation (little or no control of ejaculation at the time of penetration).
Study Endpoints
The co-primary effectiveness endpoints for the study were:
- (1) Improvement compared to baseline of the erectile function (EF) domain of the International Index for Erectile Function (IIEF) in patients randomized to Eroxon, at 24 weeks post-randomization (mean change from baseline greater than zero).
- (2) Mean change from baseline of the IIEF-EF in patients randomized to Eroxon, at 24 weeks post-randomization, greater than or equal to the minimally clinically important difference (MCID) of 4, as published by Rosen et al 2011.
The secondary effectiveness endpoints of the study were:
- (1) Mean percentage of Eroxon uses per patient that result in the patient noticing their erection starting within a certain period of time was greater than 30% during the 24-week treatment period.
- (2) Mean percentage of Eroxon uses per patient that result in the ability to have penetrative sex within a certain period of time was greater than 30% during the 24-week treatment period.
The study also had several exploratory endpoints. However, the only exploratory endpoint considered by FDA to support this De Novo submission was:
- (1) Proportion of patients reporting a meaningful improvement in the IIEF-EF domain according to the criteria published by Rosen et al 2011. assessed every 4-weeks postrandomization (evaluated by mild, moderate, and severe ED).
The effectiveness endpoints were not evaluated in comparison to the control group.
Safety Endpoints
Safety was evaluated based on treatment emergent adverse events (TEAEs) and standard physical and laboratory assessments. A TEAE was defined as any adverse event that had its onset date on or after the date of randomization and up to 7 days after treatment discontinuation.
Analysis Population
The primary analysis population for evaluation of effectiveness was the full analysis set, which included all randomized patients. The primary safety analysis was performed on the safety analysis set. which included all randomized patients who used Eroxon or the control medication at least once.
In the case of randomization/treatment errors, patients were analyzed according to their initially received treatment.
8
Study Results
While information regarding the tadalafil control is provided in this section. data from the control group is not used for comparison of safety and effectiveness against Eroxon.
Participant Disposition
The study randomized a total of 96 patients in countries of Georgia (n=30). Poland (n=54). Bulgaria (n=3), and the US (n=9). A total of 48 patients were randomized to Eroxon arm and the other 48 patients were randomized to the tadalafil 5 mg arm. The randomized patients made up the full analysis set for efficacy analyses. Of the randomized patients, 94 received treatment and were included in the safety analysis set for safety analyses. The two remaining patients withdrew consent prior to using the treatment and therefore did not complete the study.
Seven patients, 6 in the Eroxon group and 1 in the tadalafil group, withdrew from treatment. Lack of effectiveness was cited as the reason why 3 of the 6 patients in the Eroxon group withdrew from treatment. The others who withdrew from Eroxon group were for lost to followup and re-location. The one patient who withdrew from tadalafil group was due to followup.
A total of 87 patients, 41 (85.4%) in the Eroxon group and 46 (95.8%) in the tadalafil group, completed 24 weeks of treatment and the investigation.
Table 3 below summarizes the participant disposition throughout the study.
| Number of Patients | Eroxon
N = 48
n (%) | Tadalafil
N = 48
n (%) | All
N = 96
n (%) |
|--------------------------------|---------------------------|------------------------------|------------------------|
| Randomized | 48 (100) | 48 (100) | 96 (100) |
| Country of enrollment | | | |
| Georgia | 16 (33.3) | 14 (29.2) | 30 (31.3) |
| Poland | 26 (54.2) | 28 (58.3) | 54 (56.3) |
| Bulgaria | 2 (4.2) | 1 (2.1) | 3 (3.1) |
| United States | 4 (8.3) | 5 (10.4) | 9 (9.4) |
| Received study treatment | 47 (97.9) | 47 (97.9) | 94 (97.9) |
| Completed study investigation | 41 (85.4) | 46 (95.8) | 87 (90.6) |
| Did not complete investigation | 7 (14.6) | 2 (4.2) | 9 (9.4) |
| Reason for not completing | | | |
| Did not use treatment1 | 1 (2.1) | 1(2.1) | 2 (2.1) |
| Lack of effectiveness2 | 3 (6.3) | 0 (0.0) | 3 (3.1) |
| Lost to follow-up | 1 (2.1) | 1 (2.1) | 2 (2.1) |
| Moved out of country | 2 (4.2) | 0 (0.0) | 2 (2.1) |
Table 3: Patient Disposition (All Enrolled Patients)
1 Consent withdrew prior to using treatment
2 Lack of effectiveness was considered as a reason adversely related to treatment
9
Demographic and Baseline Data
The majority of male patients in each treatment group were White, with 87 (90.6%) patients overall. The remaining 9 (9.4%) were Black or African Americans, 4 in the Eroxon group and 5 in the tadalafil 5 mg group. The age range across all treatment groups was 22 to 68 years. The majority of the female partners in each treatment group for the Full Analysis Set was White, with 87 (90.6%) patients. The remaining 9 (9.4%) were Black or African American. While the study did not enroll patients of Hispanic descent, this device is not expected to perform differently in this population compared to the general US population. The age range for female partners across all treatment groups was 19 to 69 years. The mean age was 43.8 years at baseline between the groups.
The randomized groups were comparable with respect to the ED disease status but the patients in the tadalafil group were younger on average than the ones in the Eroxon group. Recruitment was stratified by ED severity with the aim to randomize and treat approximately 40 mild ED patients. 36 moderate ED patients, and 24 severe ED patients. The actual number of patients was 38, 34, and 24 for mild, moderate, and severe ED patients, respectively.
The demographics and baseline characteristics of the randomized subjects is provided in Table 4:
| Characteristics | | Eroxon
N = 48 | Tadalafil
N = 48 | All
N = 96 |
|----------------------------|------------------------|------------------|---------------------|---------------|
| Age
(years) | Mean (SD) | 46.1 (13.5) | 41.5 (11.5) | 43.8 (12.7) |
| | Median | 44.5 | 39.0 | 40.5 |
| | Minimum, Maximum | 22, 68 | 23, 68 | 22, 68 |
| Gender | Male | 48 (100%) | 48 (100%) | 96 (100%) |
| | Female | 0 (0%) | 0 (0%) | 0 (0%) |
| Race | White/Caucasian | 44 (91.7%) | 43 (89.6%) | 87 (90.6%) |
| | Black/African American | 4 (8.3%) | 5 (10.4%) | 9 (9.4%) |
| | Hispanic | 0 (0%) | 0 (0%) | 0 (0%) |
| | Other | 0 (0%) | 0 (0%) | 0 (0%) |
| ED
duration
(months) | Mean (SD) | 28.93 (32.34) | 27.28 (24.77) | 8.11 (28.66) |
| | Median | 16.02 | 16.15 | 16.15 |
| | Minimum, Maximum | 3.9, 164.6 | 5.1, 88.4 | 3.9, 164.6 |
| |