MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
Phase: NA
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Sponsor: Brigham and Women's Hospital

 
Version 2023.06.09 
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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Martin Kathrins, M.D. 
 
Project Title: 
 
A single-centre, open-label, non-randomized, home use, clinical 
investigation in the use of MED3000 Topical Gel for On-Demand 
Treatment of Post-Radical Prostatectomy Erectile Dysfunction 
 
Version: 
Version 5.1 dated 2 November 2023 
 
Phase:  
Exploratory 
 
Device:  
MED3000 gel 
 
Revision History:  
 
Version 1.0 
New Version 
Version 2.0 
Changes include: 
• 
Inclusion criterion related to IIEF-EF pre-radical prostatectomy changed to the 
use of IIEF-5 assessment 
• 
Removal of treatment for pelvic hematoma from Male exclusion criterion 2 
• 
Current use of androgen deprivation therapy added to exclusion criterion 7 
• 
Removal of severe phimosis as an exclusion criterion 
• 
Wording changed from “Prior surgical history for Peyronies disease” to “Prior 
surgery or intralesional treatment for Peyronies disease” in exclusion criteria 
• 
Inclusion of a question asking which party (male or female) predominantly 
applied MED3000 gel prior to intercourse 
• 
Other administrative changes. 
Version 3.0 
• 
Change in inclusion criterion 4 from “Normal pre-radical prostatectomy 
erectile function (IIEF-5 >21)” to “Normal pre-radical prostatectomy erectile 
function (EPIC-CP question 8 score of 0 [firm enough for intercourse])”. 
• 
Details of manufacturer updated. 
• 
Recruitment criteria changed 
 
Version 3.1 
• 
Version 3.1 not prepared. Version 3.2 was created directly from 3.0 in error. 
Version 3.2 
• 
Section 5: Additional paragraph relating to the review of patient suitability for 
the study included 
Version 3.3 
• 
Altered pathologic inclusion criteria  
• 
Details for changes for versions 3.1 and 3.2 have been added to the Revision 
History section 
• 
Amended inclusion criteria 18 to 48 months of bilateral nerve-sparing radical 

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prostatectomy, from 36 months  
• 
Removed “robotic-assisted laparoscopic only” from inclusion criterion 1 
o PCa stage =< T3a 
• 
Included “or IIEF > 26” to inclusion criterion 4 
• 
Appendix 3 [Onset of Action questionnaire] removed as not relevant in this 
study. 
Version  4.0 
• 
Administrative change- Eligibility criteria have been numbered for ease of 
referencing 
• 
Versioning corrected so that final versions are denoted using an integer 
• 
Version number has been corrected on the Approval Signature page 
• 
Massachusetts General Hospital included in Section 5.0 as a source of potential 
patients. 
Version 5.0 
• 
Clarification that the female may sign the informed consent on a date either 
before or after the patient, but both must have consented prior to any study 
related activity being performed.. 
• 
Alteration of protocol that an appropriate PSA and serum testosterone result 
within 4 months of V1 is acceptable and that a new set of lab work may not be 
necessary.  
• 
Alternation of protocol that serum assays for PSA and testosterone may be 
performed at any point between Visit 1 and Visit 2. 
• 
Removed requirement for repeat PSA assay after treatment and patient will 
instead be instructed to proceed with standard of care assays with his primary 
urologist 
Version 5.1 
• 
Clarification in Stopping/Discontinuation Rules that the end of the study is 
after Visit 6 (week 13). This is consistent with the End of Study section. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Approval Signature  
 
Version 5.0 
 
This clinical investigation plan has been approved by Dr Martin Kathrins MD 
 
Sponsor’s Signature:  
 
Sponsor and Principal Investigator: Dr Martin Kathrins MD 
 
Signature: 
 
Date: 
 
 
Sub-Investigator’s Signature:  
 
Sub-Investigator: Dr Alexandra Berger Eberhardt MD  
 
Signature: 
 
Date: 
 
 
 

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1. 
 Background and Significance 
 
Erectile dysfunction (ED) is a common side-effect after radical prostatectomy (RP), even 
with nerve-sparing techniques. Cavernosal nerve damage may be due to direct trauma, 
stretching, heating, ischemia and local inflammation. This damage may be temporary, 
and nerve transmission may be regained to some extent 1-3 years after surgery. As 
functioning nerves are necessary for erections, this means that the penile tissue is in a 
constant state of low oxygen supply during the time with nerve dysfunction. This may, in 
turn, lead to cavernosal smooth muscle apoptosis and fibrosis, which manifests as loss 
in penile length, and causes long-term ED. The anatomic nerve-sparing technique for 
radical prostatectomy has been employed for decades with the goal to preserve post-
postoperative erectile function the results are still imperfect in regard to sexual function 
recovery.2 
Penile rehabilitation post-RP with PDE5-inhibitors (PDE5i) have been postulated to 
improve cavernosal perfusion and maintain smooth muscle viability. Although the 
REACTT trial did not meet its primary end point of improved IIEF-ED over placebo at 
10.5 months after RP, there was significantly less penile shortening in the tadalafil once 
daily group (-2.2mm) over placebo (-6.3mm).3 Patients refractory to oral therapies may 
proceed to more invasive medical therapies such as penile injection therapy and even 
penile prosthesis insertion. Despite recent advancements in surgical technique and 
penile rehabilitation programs, less than 30% of men recover erectile function at one 
year post-operatively.4 
MED3000 has been shown to improve erectile dysfunction when used as needed 
(unpublished data).5 MED3000 topical gel utilizes a novel evaporative mode of action 
with a rapid onset of action within 10 minutes for most users. MED3000’s combination of 
volatile solvent components creates a novel evaporative mode of action that stimulates 
nerve sensors in the highly innervated glans penis through temperature, touch and 
pressure. It is believed that this leads to smooth muscle relaxation, tumescence and 
erection. MED3000 is non-invasive and as such does not achieve its intended purpose 
through penetration of cutaneous or mucous membranes. Patients are treated with 
topical MED3000 just prior to intercourse. MED3000 was originally studied in a 12-week 
Phase III, dose-ranging, multi-centre, randomized, double-blind, placebo-controlled, 
home use, parallel group trial. Treatment involves self- or partner-administered gel to the 
glans penis for 15 seconds prior to attempting sexual intercourse. Adverse events were 
rare and mild including headache and penile burning. There were no serious adverse 
events. (unpublished data).5 
 
It is postulated that on demand treatment with MED3000 may improve erectile function 
among men status-post radical prostatectomy, allowing for some endogenous 
cavernosal nerve function recovery for 1.5 to 3 years post-surgery among men with 
normal baseline pre-surgical erectile function. To verify that bilateral nerve sparing was 
indeed performed, nerve sparing status for each nerve (left and right) will be assessed 
by the attending surgeon documentation. This pilot study aims to explore the feasibility, 
safety and effectiveness of MED3000 topical gel for on demand therapy of erectile 
dysfunction 1.5 to 3 years status-post bilateral nerve sparing radical prostatectomy. 
Abbreviation  Explanation 
PSA 
 
Prostate specific antigen 

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ADE 
 
Adverse Device Effect 
AE 
 
Adverse event 
ED 
 
Erectile dysfunction 
EPIC  
Expanded Prostate Cancer Index Composite 
FDA 
 
United States Food and Drug Administration  
FMD   
Futura Medical Developments, Ltd 
HCV 
 
Hepatitis C 
HIV 
 
Human immunodeficiency virus 
ICF 
 
Informed Consent Form 
IIEF 
 
International Index Erectile Function 
IIEF-EF 
Erectile Function Domain of the International Index Erectile Function 
IRB 
 
Institutional Review Board 
MCID  
Minimally clinically important difference 
PI 
 
Principal Investigator 
PHRC  
Partners Human Research Committee 
SAE 
 
Serious Adverse Event 
SEAR   
Self-esteem and Relationship 
UADE  
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
UPIRTSO 
Unanticipated Problem Involving Risks to Subjects or Others 
 
2. 
Specific Aims and Objectives  
 
Primary Objective: 
1. To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction 
after nerve sparing prostatectomy (based on the Erectile Function domain of the 
International Index Erectile Function [IIEF-EF] assessed at treatment completion after 
12 weeks compared to post-washout baseline).  
2. To observe a mean change from baseline of the IIEF-EF domain in patients after 
nerve sparing prostatectomy treated with MED3000, assessed at treatment 
completion after 12 weeks, greater than or equal to the minimally clinically important 
difference (MCID) of 4, as published by Rosen et al 2011.1 
 
Secondary Objectives: 
To investigate the following in patients after nerve sparing prostatectomy treated with 
MED3000 for 12 weeks: 
 
1. The efficacy of MED3000 in patients at weeks 4, 8 and 12 using: 
a. The change from baseline in Self-Esteem and Relationship (SEAR) 
questionnaire for men 
b. The change from baseline in Urinary incontinence using the Expanded Prostate 
Cancer Index Composite (EPIC) - (climacturia question added to EPIC)  
c. Change from baseline in all domains of the IIEF. 
2. The change from baseline in 24 hour pad weight and usage number per day at 12 
weeks. 
3. The change from baseline of the stretched flaccid penile length following 12-weeks of 
treatment  
4. Treatment-related adverse events in male patients and female partners occurring 
during treatment with MED3000. 

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3. 
General Description of Study Design 
 
This is an open-label, non-randomized, single-arm trial. Patients with no evidence of prostate 
cancer biochemical recurrence (Prostate specific antigen [PSA] undetectable) with mild to 
severe post-radical prostatectomy erectile dysfunction based on IIEF-EF criteria will be enrolled. 
Patients will washout from use of prior erectogenic regimens for at least four weeks in order to 
standardize the cohort and establish a symptomatic baseline. By the 1.5 to 4 year point after 
surgery, many men may have pursued other erectogenic aids. Patients will be instructed to 
cease all erectogenic aids for at least 4 consecutive weeks prior to commencing intervention. 
Aids may include phosphodiesterase 5 inhibitors, vacuum erection device, intraurethral 
suppository, or intracavernosal injection therapy. During the 4-week Screening Period, patients 
will be advised to attempt at least 4 sexual intercourse attempts. IIEF-EF will be assessed at the 
end of this period to assess candidacy for trial and assess baseline status.  
All eligible enrolled patients will receive treatment with MED3000 topical gel and use on demand 
for up to 12-weeks. Patients will be assessed at 4 weeks, 8 weeks, and 12 weeks (treatment 
cessation) after the baseline visit (Visit 2). No other erectogenic aids are allowed during the 12-
week (±1 week) treatment period. Patients will be managed using standard of care but will attend 
the site for follow-up evaluation at 12-weeks (±1 week). Study assessments will include: IIEF, 
SEAR, EPIC and climacturia questionnaires, stretched flaccid penile length, urinary incontinence 
analysis, prostate-specific antigen (PSA) assessments, and use of other erectogenic aids 
specifically penile prosthesis placement. 
Intervention 
Patients will be instructed to make at least 4 intercourse attempts in each of the three 4-weekly 
periods during treatment (Weeks 1-4, 5-8, 9-12). Patients will apply a single dose 
(approximately 300 mg) to the glans penis and rub in for at least 15 seconds (to ensure a 
thorough distribution of gel) prior to each sexual intercourse attempt.  Patients may have 
telehealth visits at Weeks 4 (Visit 3), 8 (Visit 4) and the  13-week follow-up visit (Visit 6). The 
patient will be expected to attend the site for the Screening (Visit 1), Baseline (Visit 2), and 12 
week (Visit 5) assessments The patient reported outcome questionnaires (IIEF, SEAR, EPIC 
and climacturia) will be completed at Screening (Visit 1), Baseline (Visit 2), and the end of each 
of the 4-weekly periods (Weeks 4, 8, and 12). At study visits where it is not necessary for the 
patients to attend the site in person (Visits 3, 4, and 6), the questionnaires will be completed by 
the patients at home using paper copies of the respective questionnaires. Site staff will phone 
the patient to prompt them to complete the questionnaires and ask how many device assisted 
sexual intercourse attempts the patient had. The patients will be expected to bring the 
completed questionnaires and used and unused MED3000 tubes to site at their next on-site visit 
where a compliance assessment will be performed. 
The site will encourage patient retention in the study by following up with the patients 
periodically between study visits if there any questions or concerns from patients. Additionally, 

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the site will send reminders to the patients of upcoming on-site study visit. 
On June 6, 2022 the Food and Drug Administration determined the proposed investigation is a 
nonsignificant risk (NSR) device study because it does not meet the definition of a significant 
risk (SR) device under 21 CFR 812.3 (m) of the investigational device exemptions (IDE) 
regulation (21 CFR 812).  
Safety will be evaluated throughout the study, whilst patients are on treatment by evaluating all 
reported adverse events (AEs) and the use of concomitant treatments. Additionally, standard 
assessments including physical examinations and visual examination of the penis, vital signs 
(BP, heart rate [HR], body temperature) will be conducted at the screening and baseline visits 
(Visits 1 and 2), and Week 12 (Visit 5). Details relating to AEs and concomitant medication will 
be collected during the patient’s study contact with the site.  
International Index for Erectile Function (IIEF) questionnaire 
The IIEF was developed and validated in 1996–1997 as part of the sildenafil clinical study 
program and in 1999, the IIEF was recommended by the first International Consultation on 
Erectile Dysfunction as the primary effectiveness endpoint of choice for clinical studies in ED.6,7 
After years of use, the IIEF is considered the gold standard self-report questionnaire for 
measuring EF. The IIEF has been validated, is widely used in numerous countries, and has 
demonstrated specificity for detecting treatment-related changes in EF.8 The IIEF consists of 15 
questions divided into five domains of sexual function: EF (6 questions), orgasmic function (2 
questions), sexual desire, (2 questions), intercourse satisfaction (3 questions) and overall 
satisfaction (2 questions). A score of 0 to 5 is awarded to each of the 15 question.6 Higher 
scores indicate better sexual function. The IIEF-EF domain, a subset of the IIEF measuring 
erection function, is commonly used as the primary endpoint in clinical trials and comprises 
Questions 1–5 and 15 of the IIEF. The questionnaire is completed by a patient’s recollection of 
the effects that his erection problems have had on his sex life over the previous 4 weeks. 
Objective Performance Criteria and Clinically Meaningful Differences 
Objective performance criteria (OPC) are standardized numerical target values derived from 
historical data taken from clinical studies and/or registries that may be useful for the review and 
comparison of safety or effectiveness endpoints in novel trials. OPC serve as additional 
evidence for the effectiveness of MED3000. 
 
In 2011 Rosen et al. published a paper titled ‘Minimally clinically important differences in the 
erectile function domain of the International Index of Erectile Function scale’.1 In this paper, the 
EF domain of the IIEF questionnaire were questions 1 to 5, inclusive, and question 15. The 
study used anchor-based minimal clinically important differences (MCIDs) estimated using data 
from 17 randomized, double-blind, placebo-controlled, parallel-group clinical trials of the PDE-5 
inhibitor tadalafil (Cialis®) for 3,345 men with ED who received treatment for 12 weeks (meta-
analysis). An overall MCID for IIEF-EF change from baseline of 4 was established across all ED 

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severities. MCIDs for IIEF-EF changes from baseline were also established for different ED 
severities as follows: mild, 2; moderate, 5; and severe, 7. These ‘Rosen’ criteria have now been 
widely accepted and used for responder definitions by academia and leading experts in the field 
of ED, and are cited by the US FDA in a recent strategic review as an acceptable patient 
reported outcome. 
Self-Esteem And Relationship (SEAR) questionnaire 
The Self-Esteem And Relationship (SEAR) questionnaire has strong psychometric properties 
that support its validity and reliability for measuring sexual relationship satisfaction, overall 
relationship satisfaction, confidence and particularly self-esteem in men with ED.9  
It consists of 14 items investigating two dimensions: sexual relationship satisfaction (8 items) 
and confidence (6 items; subdivided into self-esteem and overall relationship satisfaction). All 
items are scored on a 5-point Likert-type scale. A higher score signifies a more favorable 
response for all 14 items. The questionnaire is completed by a patient’s recollection over the 
previous 4 weeks. 
EPIC: The Expanded Prostate Cancer Index Composite 
The Expanded Prostate Cancer Index Composite is a validated patient related outcome mean to 
monitor quality of life in prostate cancer survivors. The evaluated data points include urinary 
incontinence, lower urinary tract symptoms, sexual, gastrointestinal, and hormonal on a scale of 
0 to 100. The 26 question form is referred to as the Short Form. 10,11 The questionnaire is 
completed by a patient’s recollection over the previous 4 weeks. We have added a question 
specifically regarding climacturia, which is the occurrence of urinary incontinence during sexual 
activity.   
Minimally Important Differences have been studied for the various sub-categories of EPIC Short 
Form. (Skolarus et al 2015).  
 
Identification and Description of the Investigation Device 
 
Details of the manufacturer: 
BCM LTD 
(BOOTS CONTRACT MANUFACTURER) 
D10 THANE ROAD 
BEESTON 
NOTTINGHAM 
NG902PR 
UNITED KINGDOM 
 
Name/Number of model to permit full identification: 
Not applicable. 
 
Device traceability: 

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MED3000 gel will be supplied to the site in single-dose tubes contained within an outer carton 
(each carton contains 4 tubes). Both carton and tubes will display details of the investigational 
device’s batch number and unique kit identification number. The labels applied to the MED3000 
will comply with the requirements of 21 CRF 812.5. 
 
After a patient is deemed eligible to participate (Visit 2), each patient will be provided with 
sufficient medication for the entirety of their participation in the study (9 carton [36 tubes]). It is 
assumed that each patient will make no more than 12 intercourse attempts using MED3000 gel 
within each 4-week treatment period. 
 
Traceability of dispensed and returned investigational product (i.e. MED3000 gel) will be 
managed using site maintained dispensing/return logs. 
 
Details of device components:  
 
MED3000 is a clear to turbid gel free from particulate matter and is composed of the following 
ingredients: water, ethanol, propylene glycol, glycerine, carbomer, and potassium hydroxide 
(Table 1). All ingredients are commonly used in topical formulations. 
 
Table 1. MED3000 Qualitative Formula 
 
 
Component 
Specification 
Function 
Alcohol 
USP 
Volatile 
component 
Purified water 
USP 
Volatile 
component 
Glycerin 
USP 
Non-volatile 
vehicle 
Propylene glycol 
USP 
Non-volatile 
vehicle 
Carbomer interpolymer type A (Carbopol 
Ultrez-10) 
NF 
Viscosity modifier 
Potassium hydroxide solution (18% w/w) a 
NF 
pH modifier 
NF=National Formulary; USP=United States Pharmacopoeia; w/w=weight for weight 
a  Potassium hydroxide is added to adjust to a pH of 5.5. 
 
 
 

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Summary of required training: The device is applied to the glans penis immediately prior to 
sexual intercourse. The site staff will provide training to eligible patients with or without their 
partner how MED3000 gel should be applied to the glans penis prior to dispensing the product. 
Further training may be provided to the participants as required. Previous studies have 
demonstrated that MED3000 gel is a safe product with an extremely favorable safety profile. 
 
 
4. 
Subject Selection 
 
All patients who underwent bilateral nerve sparing radical prostatectomy through Brigham and 
Women’s Hospital / Brigham and Women’s Faulkner Hospital may be considered for this study. 
Men who have undergone radical prostatectomy have obstructive azoospermia/anejaculation 
and are infertile in regard to any potential for natural conception through intercourse.  
 
Patients will be recruited through the active patient cohort of the Brigham and Women’s urologic 
men’s health clinic which has a large patient volume of men with erection dysfunction following 
radical prostatectomy. Approximately 20 patients will enter the treatment phase of this study.  
Male subject inclusion criteria 
1. Men who underwent bilateral nerve-sparing radical prostatectomy between 18 and 48 
months prior to study commencement  
2. Age 40 – 70 at the time of screening.  
3. Diagnosed with prostate cancer: 
a. PSA < 20 ng/ml 
b. Gleason score =< 8 
c. PCa stage =< T3a 
4. Normal pre-radical prostatectomy erectile function (EPIC-CP question 8 score of 0 [firm 
enough for intercourse] or IIEF > 26) 
5. Baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any 
kind) and at enrolment following washout (IIEF-EF domain <=25) 
6. Sexually active, in a stable heterosexual relationship for at least 6 months prior to 
screening 
7. Female partner meets their respective inclusion and exclusion criteria 
8. Able to understand and complete patient questionnaires 
9. Serum PSA undetectable (no evidence of disease recurrence) 
10. Willing and able to provide written consent to participate in the study (note: both the patient 
and his female partner must provide written consent to participate before any study related 
procedure is undertaken) 
11. Willing to refrain from the use of other erectogenic devices and pharmaceutical 
interventions during the washout and 12-week treatment periods. 
Male subject exclusion criteria  
1. Anatomical abnormalities in the genitalia or pelvic region such as severe phimosis  
2. Post-RP complications that could impact safety or effectiveness of medical therapy for 

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erectile function (urinary or intestinal fistula, unresolved anastomotic leak) 
3. Tumor upstaging beyond T3a 
4. Incomplete / sub-total nerve sparing on either side 
5. Previous or scheduled treatment with pelvic salvage radiotherapy and/or androgen 
deprivation therapy 
6. Prior receipt of androgen deprivation therapy  
7. Unwillingness of the patient to make the required attempts at sexual intercourse during 
the screening period (at least 2 sexual intercourse attempts) and during the 4-weekly 
assessment periods (at least 4 sexual intercourse attempts per period) in the treatment 
phase. 
8. Patient cannot communicate reliably with the Investigator 
9. Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, 
hematological, endocrinological, metabolic, neurological or psychiatric disease 
which, in the opinion of the Principal Investigator, renders the male patient unfit to 
take part in the investigation 
10. Patient has any history of an unstable medical or psychiatric condition or using any 
medication that, in the opinion of the PI, is likely to affect the patient’s ability to 
complete the investigation or precludes the patient’s participation in the investigation 
11. Hypersensitivity to any of the excipients 
12. Any clinically significant abnormal laboratory, vital signs or other safety findings as 
determined by medical history, physical examination or other evaluations conducted 
at screening or on admission 
13. History of severe uncontrolled diabetes 
14. Patients with nursing partners, known pregnant partners or partners who wish to 
become pregnant  
15. Clinical evidence of alcohol or drug abuse (including marijuana) (in last 12 months) 
16. Patients receiving testosterone pellets 
17. History of hypogonadism  
18. Prior surgical or intralesional treatment for Peyronie’s disease 
19. Any other condition that would prevent the patient from completing the study, as 
judged by the Investigator 
 
Female partner inclusion criteria  
1. Willing and able to provide written consent to participate in the study (note: both the 
patient and his female partner must provide written consent to participate before any 
study related procedure is undertaken) 
2. Documented written informed consent  
 
Female partner exclusion criteria  
1. Unwillingness of the partner to make the required attempts at sexual intercourse during 
the screening period (4 requested sexual intercourse attempts) and during the 4-
weekly assessment periods (4 requested sexual intercourse attempts per period) in 
the treatment phase. 
2. Unwilling to disclose any experienced adverse events to the site study team. 
3. Partner cannot communicate reliably with the Investigator 
4. Any other condition that would prevent the patient from completing the study, as 
judged by the Investigator 

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5. 
Subject Enrollment 
 
Patients will be recruited through the active patient cohort of the Brigham and Women’s urologic 
men’s health clinic and Massachusetts General Hospital. Approximately 20 patients will enter 
the treatment phase of this study. 
The recruitment of patients will primarily be undertaken by research assistant(s) and/or 
Investigator(s) through the men’s health clinic patient cohort, with a research assistant and/or 
investigator available to support any eligible and interested patients.  Patients will initially be 
approached by his/her healthcare provider who is known to the potential patient and has first-
hand knowledge of the patient’s medical history. The healthcare provider may be one of the 
investigators. We will mitigate the possibility of undue influence when subjects are enrolled from 
among the Investigators’ own patients. We plan to employ the following approaches as 
appropriate separately or in combination:  
• 
Contact the patient in writing initially (via Research Invitation) and allow a patient 
to make the first contact if they’re interested 
• 
Ask a physician colleague, research nurse, or clinical research coordinator to 
initially explain the study or to re-contact the potential subject after the 
Investigator has presented the study at a routine in-person or telehealth visit 
• 
Offer patients the opportunity to take home the Consent Form, and call or 
message back if they wish to participate 
We will also review operative records at Brigham and Women’s Hospital, and Faulkner Hospital 
for those patients who have undergone radical prostatectomy surgery during the enrolment 
period. These patients may not have recently seen a Brigham-affiliated clinician. We will access 
the operative reports and patient medical records through the electronic medical record. We will 
screen the medical records for relevant enrolment and exclusion criteria such as nerve sparing 
status, pathology for stage and margin status, PSA status, presence of erectile dysfunction. If 
patients are deemed to be potential subjects and have not opted out of receiving research 
invitations, we will send either a targeted research announcement or personalized research 
announcement to advise them of the study. If the patient is not enrolled in Patient Gateway we 
may mail the personalized research announcement. If we have not heard back from the patient 
after a week we will call them. If patients respond favorably they will complete pre-screening 
over the phone.  
Once the provider gives approval to the research team to continue with contacting the patient, 
with the patient’s verbal permission, during the course of providing medical care, the research 
assistant or investigator will be introduced to the patient and will be available to support any 
eligible and interested patients. The subjects will not be paid for their participation in the study.  
The consenting procedure for the trial will be administered by the members of the investigator 
site study team. 

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The female partner of the patient will accompany the male patient to his appointment and be 
informed about the study and asked to participate at the initial visit. The female partner will 
review and sign her own version of the informed consent form. Both patient and partner must 
sign their respective informed consent forms before any study related procedure is carried out 
on either party. 
It is not anticipated that advertising will be needed to recruit patients and their partners. Instead, 
other clinics within Brigham and Women’s Hospital/Dana Farber Cancer Institute may cross-
refer any suitable patients as necessary. 
All potential patients will have the medication risks and possible benefits explained to them and 
given sufficient time to ask questions and consider whether they wish to participate. Only 
patients and female partners who have signed the IRB approved informed consent forms may 
be enrolled into the study. 
Non-English speakers, children and those lacking capacity will not be offered participation in the 
study. Following the Partners Human Research Committee (PHRC) policy on Obtaining and 
Documenting Informed Consent of Subjects who do not Speak English, non-English speaking 
patients will not be recruited as a full-translation consent is not available. 
Patients will be allowed to withdraw consent at any time without compromising their future 
clinical care. 
 
Most patients with post-radical prostatectomy erectile dysfunction treated at Brigham and 
Women’s Hospital/Dana Farber Cancer Institute are internally referred to PI or sub-investigator 
for management. Thus, recruitment from the patient cohort treated by PI or sub-investigator 
reflects the general population of post-prostatectomy men treated at the institution. Trial 
information will be disseminated to medical oncology, radiation oncology, and urologic oncology 
at / Brigham and Women’s Hospital / Dana Farber Cancer Institute/ Massachusetts General 
Hospital. Before patients are approached by the investigation site staff regarding study 
participation, a health care provider, usually a physician, known to the potential subject and has 
first-hand knowledge of the patient's medical history will (1) give approval for his/her patient to 
be contacted for research purposes, (2) initially introduce the study to the patient and (3) obtain 
the patient's permission to be contacted by study staff. The healthcare provider can introduce 
the study and obtain the patient's permission to be contacted by study staff verbally during the 
course of providing medical care. 
Data on patient enrolment including race and ethnicity and plan to perform sub-group analyses 
for efficacy will be recorded. The investigation site staff will reach out to providers in medical 
oncology, radiation oncology, and urologic oncology to inform them of the study and encourage 
them to contact research group with potential research subjects, irrespective of whether the 
patient is met in clinic or via telehealth visit by the primary health care provider. It is planned that 
visits performed during the study will be via Telehealth, thus limiting the burden of travel for in-
person visits.  

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6. 
STUDY PROCEDURES 
 
Patients will be screened by the research assistant and/or investigator according to the specific 
inclusion/exclusion criteria. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Schedule of Assessments (Core Investigation) 
  
Screening 
 
(5 or 4 
weeks 
before Day 
1)1 
Treatment Period (12 Weeks) 
Follow-up 
Visit 
 
 
Visit 1 
Visit 2  
 
(Day 1) 
Visit 32  
 
(Week 4 ± 1 
week) 
Visit 42 
  
(Week 8 ± 1 
week) 
Visit 57 
 
(Week 12 ±1 
week) 
Visit  62  
 
(Week 13 ±1 
week) 
Eligibility 
assessment of 
male  & female 
X 
X3 
 
 
Informed 
consent (male 
and female)9 
X 
 
 
 
PSA Serum8 
X 
 
 
 
 

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Screening 
 
(5 or 4 
weeks 
before Day 
1)1 
Treatment Period (12 Weeks) 
Follow-up 
Visit 
 
Hormonal 
assays 
(testosterone)8 
X 
 
 
 
Genital 
examination 
X 
 
 
          X 
 
BMI 
X 
 
 
 
IIEF 
X 
X4 
X 
X 
X 
 
EPIC + 
climacturia 
X 
X 
X 
X 
X 
 
SEAR 
X 
X4 
X 
X 
X 
 
Heart rate and 
blood pressure 
X 
X 
 
X 
 
Penile length 
measurement 
X 
 
 
X 
 
24 hour pad 
weight and  
number of 
pads used  
X 
 
 
 
X 
 
Treatment 
 
 
 
 
 
 
MED3000 
dispensing 
 
X5 
 
 
 
 
Adverse 
events 
reporting 
(including 
device 
deficiencies)6 
 
 
 
 
 
 
Concomitant 
treatment 
 
 
 
 
 
 
 
 1 Patients using ED treatment (device or medication), a 5-week screening period will be 
observed (including 1 week washout). Patients not using any form of ED treatment only need to 
observe a 4-week screening period).  
2 Assessments at this Visit may be performed via Telehealth. The site will phone the patients to 
prompt them to complete the IIEF, SEAR, EPIC and climacturia questionnaires, if required in the 

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protocol schedule of assessments. The completed questionnaires will be brought to the site at 
the next scheduled on-site visit. 
3 Eligibility assessment at Visit 2 will consider whether the patient has had the 4 requested 
sexual intercourse attempts during the screening period and has a score of <= 25 on the IIEF-
EF questionnaire at Visit 2. 
4 IIEF, EPIC, climacturia, and SEAR Baseline scores will be obtained at Visit 2 
5 At Visit 2, sufficient MED3000 will be dispensed to meet the needs of each patient’s entire 
participation in the study (36 tubes) 
6 Adverse Events will be recorded from the point that patient and partner sign their respective 
informed consent forms. 
7 Visit 5 assessments will be undertaken for patients who withdraw from the treatment period 
prematurely 
8 PSA and testosterone samples do not need to be drawn if the patient has had these 
completed within 4 months of the Visit 1 visit. Samples may also be drawn at a timepoint 
between Visits 1 and 2 as long as they are available to assess eligibility at Visit 2. 
9 The female may sign the consent form at a date either prior to or after the patient provides 
consent. However, both patient and partner must sign their respective consent forms before any 
study related activity begins such as male lab draws and avoidance of erectogenic aids.  
 
 
 
Study Visits 
Screening Visit (Visit 1- on site): Patients and their respective partners will visit the site to be 
consented and have their eligibility assessed. If more convenient for the patient’s partner, she 
may complete her in-person Visit 1on a date prior to or after the patient provides his consent. 
However, both patient and partner must have given consent before any study related activity is 
undertaken. PSA serum and hormonal assay samples will be taken. PSA and hormonal 
(testosterone) assay results are acceptable for review if completed within 4 months of Visit 1, 
completed on the day of Visit 1, or completed between V1 and V2 (e.g., during the screening 
period). Patients will complete the IIEF, EPIC, climacturia and SEAR questionnaires. The 
patient’s penile length will be measured, 24-hour urine pad weight and number of pads used will 
be assessed, and concomitant treatment and AE information collected. The patient’s BMI, heart 
rate and blood pressure will be measured, and a genital assessment of the patient performed. 
 
Baseline Visit (Visit 2- on site): Men will have their eligibility reaffirmed at the site. Patients will 
complete the IIEF, EPIC, climacturia and SEAR questionnaires and have their heart rate and 
blood pressure  taken. If the patient continues to be eligible, MED3000 treatment will be 
dispensed and training on the use of the treatment provided to both the patient and, if present, 
their partner. The site will record any new or changes to existing AEs. Additionally, the site will 
record any new or changes to concomitant mediation being taken. Patients will be given paper 
copies of the IIEF, EPIC, climacturia and SEAR questionnaires to allow them to complete these 
assessments at TeleHealth Visits 3, and 4.  
 
Visit 3 (phone -Week 4 (± 1 week): Patients will be asked to complete the paper IIEF,  EPIC, 
climacturia and SEAR questionnaires. The patient will bring the completed questionnaires to the 
Commented [AG1]: I have modified the requirement her 
because the female, in effect, is a participant in the study 
and the IRB may believe that their not being allowed a voice 
in the consenting process is unethical. Also, if the female 
refuses to participate then the assessments undertaken a 
V1 will have been unnecessary. 

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site at Visit 5 Adverse events. Protocol compliance will be assessed by questioning the patient 
about their use of MED3000 and the number of unused tubes of MED3000 available. Patients 
will be asked about any changes to their concomitant medication and any new or changes to 
AEs (including their partner). Additionally, patients will be asked whether the patient or partner 
predominantly applied the gel to the glans penis prior to sexual intercourse. 
 
Visit 4 (phone -Week 8 (± 1 week): Patients will be asked to complete the IIEF, EPIC, 
climacturia and SEAR questionnaires. The patient will bring the completed questionnaires to the 
site at Visit 5.  Protocol compliance will be assessed by questioning the patient about their use 
of MED3000 and the number of unused tubes of MED3000 available. Patients will be asked 
about any changes to their concomitant medication and any new or changes to AEs (including 
their partner). Additionally, patients will be asked whether the patient or partner predominantly 
applied the gel to the glans penis prior to sexual intercourse. 
 
Visit 5  (on-site -Week 12 (± 1 week): Patients have PSA serum samples taken and have a 
genital examination. Patients will also complete the IIEF, EPIC, climacturia and SEAR 
questionnaires. An assessment of the stretched flaccid penile length will be performed, heart 
rate and blood pressure will be measured. AEs, changes in concomitant treatment, and protocol 
compliance and a genital assessment will be assessed. The patient will return all used 
MED3000 tubes and unused MED3000 treatment at this visit and full verification of MED3000 
usage compliance determined. The site will also perform an assessment of the patient’s 24 hour 
pad weight and the number of pads used. Additionally, patients will be asked whether the 
patient or partner predominantly applied the gel to the glans penis prior to sexual intercourse. 
 
Follow-up Visit 6 (phone-7 day post-study treatment, (± 2 days)): Patients will provide details 
about ongoing or new adverse events and any new concomitant treatment. Usage of 
erectogenic aids will also be recorded. Patient will be instructed to continue with his primary 
urologist for PSA monitoring per standard of care.  
 
End of Study Definition  
The study ends once the last patient enrolled in the study has undergone Visit 6 or lost to follow-
up. 
 
Assessment of Safety 
 
Safety monitoring will be performed in the following manner: The investigator will routinely 
monitor each subject and their partner for the occurrence of AEs or any unusual medical 
occurrence. This will include a genital examination of the patient before and after MED3000 

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topical gel treatment, as well as interviews with each subject during each treatment visit and the 
Follow-up Visit. In addition, all subjects will be provided with a telephone number to call in case 
of medical emergencies, or to report AEs at any time.  
 
The Principal Investigator will follow IRB policy that any Unanticipated Problem Involving Risks 
to Subjects or Others (UPIRTSO) or Unanticipated Adverse Device Effects (UADE) are reported 
to the IRB within 5 working days/7 calendar days of the date the investigator first becomes 
aware of the problem. Additionally, the PI will maintain an Adverse Event Log for the duration of 
the study. 
 
A description of each AE will be recorded including the date of onset, time course, severity, 
relatedness to study treatment, action taken regarding the study treatment, outcome, and any 
treatment administered. The investigator will list the specific diagnosis, disease, or syndrome 
rather than associated signs and symptoms.  
 
All serious adverse events (“SAEs”) will be followed by the investigator until resolution or 
stabilization and reported to the IRB as per the local requirements. Any SAE that is related to 
MED3000 treatment, or is a not expected occurrence, will be reported within 24 hours of 
knowledge of the event to the device provider (Futura Medical Developments Limited).  
 
Occurrence of an SAE during the treatment period may result in termination of study treatment.  
 
A subject may be withdrawn by the investigator, regardless of consent, if the investigator 
determines health and/or safety concerns preclude continuation of investigational product 
treatment. 
 
 
 
Adverse Events 
 
AEs will be monitored and assessed throughout a patient’s involvement in the study (from the 
point of signing the ICF to the follow up visit (Visit 6). At each study visit, the site staff will ask 
the patient about any AEs the patient and their partner may have experienced.  The site study 
staff will also ask the patient about any device deficiencies that they experienced. 
 
 
Adverse Event Grading Scheme 

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Causality/relationship and intensity of an AE to the device, or affected site will be determined by 
the investigator and will be classified as one of the following: 
 
Unrelated 
The event is clearly related to an event that may be due to environmental 
or accidental occurrence or other factors such as the subject’s clinical 
state, therapeutic interventions, or concomitant drugs administered to the 
subject. 
Possibly 
related 
The event follows a reasonable temporal sequence from the time of drug 
administration or use of device, and/or follows a known response pattern to 
the study drug or device, but could have been produced by other factors 
such as the subject's clinical condition, therapeutic interventions, or 
concomitant drugs administered to the subject. 
Probably 
related 
 
The event follows a reasonable temporal sequence from the time of drug 
administration or use of device, and follows a known response pattern to the 
study drug or device, and cannot be reasonably explained by other factors 
such as the subject's clinical condition, therapeutic interventions, or 
concomitant drugs administered to the subject. 
Related 
The event follows a reasonable temporal sequence from the time of drug 
administration or use of device, and follows a known response pattern to the 
study drug or device, and cannot be reasonably explained by other factors such 
as the subject's clinical condition, therapeutic interventions, or concomitant 
drugs administered to the subject, and either occurs immediately following 
study drug administration or use of device or improves on stopping the study 
drug or device, or reappears on repeat exposure. 
 
Severity: events will be classified as outlined in the below table, which reflects the Common 
Terminology for Adverse Events (“CTCAE”) scale.  
 
Grade 
Description 
1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
2 
Moderate; minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental ADL*. 
3 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self 
care ADL**. 
4 
Life-threatening consequences; urgent intervention indicated. 
5 
Death related to AE. 
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc. 
**Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden. 

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A Serious Adverse Event (“SAE”) is an AE that meets one or more of the following criteria: 
• 
Fatal; 
• 
Life threatening; 
• 
Results in an unanticipated or prolonged hospitalization; 
• 
Results in a significant and persistent disability/incapacity; 
• 
Results in a congenital anomaly or birth defect. 
 
 
Adverse Device Effect (ADE) 
 
An AE related to the use of the investigational medical device. This 
definition includes: 
• 
 AEs resulting from insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the investigational medical 
device (malfunction is the failure of an investigational medical device to perform in 
accordance with its intended purpose when used in accordance with this protocol) 
• 
Any event resulting from use error or from intentional misuse of the investigational 
medical device (user error is user action or lack of user action while using the medical 
device that leads to a different result than that intended by the manufacturer or 
expected by the user) 
 
Device Deficiencies 
 
Serious Adverse Events (SAE) 
 
A Serious Adverse Event (SAE) is any AE that leads to any of the following: 
• 
Death 
• 
A serious deterioration in the health of the patient or the patient’s partner by one or 
more of the following: 
o A life-threatening illness or injury, or 
o A permanent impairment of a body structure or a body function including chronic 
diseases, or 
o In-patient or prolongation of hospitalization, or 
o Medical or surgical intervention to prevent a life-threatening illness or injury, or 
permanent impairment to a body structure or body function 
• 
Foetal distress, foetal death, a congenital abnormality, or birth defect including physical 
or mental impairment 
 
Note: In this study, planned hospitalization for a pre-existing condition, or procedure required by 
the protocol without serious deterioration in health will not be considered an SAE. SAEs will be 
reported to the Institutional Review Board and other required authorities within the required 
timeframe. 

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Serious Adverse Device Effect (SADE) 
 
An ADE which results in any of the consequences as characterized in an SAE. 
 
Serious Health Threat  
 
Signal from any AE or device deficiency that indicates an imminent risk of death or a serious 
deterioration in the health in patients, users or other persons, and that requires prompt remedial 
action for other patients, users or other persons. A device deficiency is the inadequacy of a 
medical device with respect to its identity, quality, durability, reliability, usability, safety or 
performance. 
 
Unanticipated Serious Adverse Device Effect (USADE) 
 
A SADE which by its nature, incidence, severity or outcome has not been identified in the 
current risk assessment. In some regions, this may be referred to as an Unanticipated Adverse 
Device Effect. 
AEs/ADEs will be collected from the signing of the ICF at screening (Visit 1) until the end of the 
investigation. Any AEs that are unresolved at the patient’s last AE assessment during the 
investigation (i.e. at the patient’s final investigation visit) are to be followed up by the PI for as 
long as medically indicated, but without further recording in the eCRF. FMD retains the right to 
request additional information for any patient and/or their female partner with ongoing 
AE(s)/SAE(s) at the end of the investigation, if judged necessary. 
All AEs/ADEs will be recorded in the patient’s paper diary and entered into the eCRF after 
review by the PI or suitable qualified designee (e.g. sub-investigators) at the next investigation 
visit. The details to be recorded are: 
• 
The date of the AE/ADE onset and its resolution 
• 
Treatment (if any) 
• 
Seriousness 
• 
Relationship to the investigational device or control and the related procedure 
 
Any SAE/SADE/USADE will be notified by the PI or designee to the IRB and other authorities as 
per local regulations and requirements. 
 
Concomitant Treatment 
 
The use of any concomitant treatment will be monitored throughout the study from the point of 
signing the ICF at Screening Visit (Visit 1) until the final study visit. The site will ask the patient 
about any concomitant treatment the patient is taking or any changes in concomitant treatment 
at each of the study visits.  

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Patients are not permitted to take other forms of erectogenic treatment during their participation 
in the study. Erectogenic treatments may include PDE5i inhibitors such as sildenafil citrate, 
vardenafil and tadalafil or mechanical devices used to treat erectile dysfunction. 
Central/Local Laboratories  
Analysis of serum PSA and hormonal (testosterone) assessment will be performed by Mass 
General Brigham central clinical laboratory or another certified laboratory (if the patient prefers).  
 
7. 
Risks and Discomforts 
 
Anticipated Adverse Events Associated with MED3000 topical gel: 
• 
Penile pain/discomfort 
• 
Headache 
 
Adverse Events Associated with Blood Draws  
• 
Infection at blood sampling site 
• 
Pain at blood sampling site 
• 
Hematoma or thrombus 
• 
Extensive bleeding 
• 
Nerve Damage 
• 
Vasovagal reaction Syncope, fainting  
• 
Allergic Reaction 
 
Of note, in regard to patients status-post radical prostatectomy for prostate cancer, 
approximately 20-40% of patients with clinically localized prostate cancer may present tumor 
biochemical recurrence after radical prostatectomy. There is no anticipated risk of biochemical 
recurrence with MED3000 topical gel. 
All SAEs will be recorded and reported to IRB as required by their regulations. 
 
8. 
Benefits 
 
Patients may not directly benefit from taking part in this research study. Other men with post-
radical prostatectomy erectile dysfunction and their female partners may benefit in the future 
from what we learn in this study. 
Patients may benefit from improvements in erectile function and quality of life.  
9. 
Statistical Analysis 
Sample size calculation  
It is planned to enrol and treat approximately 20 patients for a 12-week treatment duration. 
There is no formal sample size calculation performed. This is an exploratory study for treatment 
of novel patient population without precedent.  

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Statistical analysis 
Baseline characteristics of the trial participants will be summarized using the following baseline 
data. Mean, median, minimum, maximum and standard deviation or proportion (as appropriate) 
will be reported.  
• 
Age 
• 
Baseline comorbidities  
• 
BMI 
• 
Baseline IIEF/ SEAR/EPIC (+climacturia question) (following 4 week screening period) 
• 
24 hour pad weight 
• 
24 hour pad number usage 
• 
Stretched penile length  
• 
Prostate cancer stage (surgically-verified) 
 
Full Analysis Set: Patients who received at least one dose MED3000 topical gel treatment. 
Per-protocol Analysis Set: Patients who meet the inclusion/exclusion criteria and who have 
completed all the treatment and follow-up sessions up to the 12-week visit. 
 
Analysis of Primary Efficacy Endpoint  
 
The primary efficacy assessment is the mean change in IIEF-EF from baseline (post 4-week 
washout) at 12 weeks. The observed primacy efficacy assessment will be compared to the 
MCID of 4. 
 
Analysis of Secondary and Safety Endpoints 
 
The secondary assessments are: 
 
• 
Mean change from baseline in all domains of the IIEF at 4, 8 and 12 weeks, besides the 
IIEF-EF at 12 weeks. 
• 
Mean change from baseline in SEAR, EPIC at 4, 8 and 12 weeks 
• 
Mean change from baseline in stretched flaccid penile length at 12 weeks 
• 
Proportion of patients on penile injection therapy or penile implant at 12 months follow-up 
• 
Mean change in 24 hour pad weight and 24 hour pad number usage at 12 weeks 
• 
Serum PSA indicative of biochemical recurrence 
• 
Proportion of patients who experienced treatment-related adverse events 
 
 
Continuous variables: Estimates of mean changes from baseline, along with 95% confidence 
intervals, will be produced. The change from baseline in endpoints within the group will be 
analysed by one-sample t-tests with a two-sided significance threshold of p=0.05, testing the 
null hypotheses of mean change from baseline equal to zero. Covariates / sub-groups may also 
be evaluated such as age and comorbidities.  
 

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Discrete variables: Estimates of proportions, along with 95% confidence intervals, will be 
produced. 
Any missing, impossible (inconsistent with human life) or inconsistent recordings in the Case 
Report Forms will be referred back to the Principal Investigator and documented for each 
individual patient before clean file status is declared. Missing data will not be imputed.  
Data will be analyzed with Microsoft Excel, Graphpad Prism 7, or equivalent statistics software. 
Efficacy endpoints will be analysed after the last patient has completed all follow up visits. 
10.   Monitoring and Quality Assurance 
 
The principal investigator will provide monthly status updates to FMD in regard to any 
unanticipated AEs, SAEs etc. in addition to standard reporting of such events to IRB.  
 
Withdrawal Criteria 
 
• 
Occurrence of a serious adverse event during the treatment period will result in 
termination of MED3000 topical gel treatment. 
• 
A subject may be withdrawn from MED3000 topical gel treatment by the investigator, 
regardless of consent, if the investigator determines health and/or safety concerns 
preclude continuation of investigational product treatment. If a subjective is not 
sufficiently cooperative may be grounds for dismissal from trial participation.  
• 
A subject may be withdrawn from the study by the investigator in the event that a late 
inclusion/exclusion criteria violation is found to have occurred and there are 
corresponding health and/or safety concerns.  
• 
Tumor recurrence (defined as biochemical recurrence: serum PSA ≥ 0.2 ng/ml) during 
the MED3000 treatment period will result in immediate withdrawal from the study such 
that adjuvant/salvage therapies for cancer control will be needed.  
• 
A subject may withdraw from the study at any time, for personal reasons or otherwise.   
 
Information regarding the timing and type of withdrawal (treatment and/or study) will be 
documented. Information collected for study purposes may be maintained and used by 
investigators after study withdrawal has occurred, but no new information will be collected after 
that time. Subject withdrawal due to an AE will be distinguished from withdrawal due to other 
reasons by appropriate documentation. 
Stopping / discontinuation rules 
Completion of trial is defined as the point at which the last patient enrolled in the study has 
completed the visit 6 (week 13) follow-up phone call visit or withdrawn from the study.  
Although unlikely to occur, the study may also be terminated early if recurrent serious protocol 
deviations are reported, and/or the study team is unable to continue (e.g. manpower or financial 
issues). In this case, a report will be filed with the IRB within 1 month, and all treated patients 

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will continue to be followed up until follow-up visit (Visit 6) if possible and undertake the 
assessments scheduled for each visit. 
The final clinical study report will document the reasons for trial discontinuation if it occurs. 
Deviations from the Protocol 
Emergencies excepting, under no circumstances will prospective deviations (waivers) from the 
approved Clinical Investigation Plan and subsequent amendments be permitted. Any changes 
to the approved protocol should be covered by an amendment which will be approved by the 
necessary Regulatory Authorities and/or IRB as necessary. 
All deviations that are identified during the course of the study, be they major or minor in 
severity, will be recorded on a protocol deviations tracking log. This log will be reviewed by the 
site staff periodically for risk and trend evaluation purposes, and corrective and preventative 
actions taken as necessary. Futura will be notified of all protocol deviations as part of the PI’s 
periodic update reports. 
Monitoring, quality control and assurance 
The study coordinator or designee is responsible for quality control of the data. 
The manufacturer (Futura Medical Developments Ltd) or appointed party has the option to 
monitor the data and perform onsite monitoring visits to ensure the precision, quality, and 
integrity of the data collected.  The investigator(s) agrees to permit access to study records, 
source data, and source documents for this purpose 
 
11.   Privacy and Confidentiality 
 
☒ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with appropriate 
protections such as password protection, encryption, physical security measures (locked 
files/areas) 
☒ Specimens collected will be maintained in a secure location with appropriate protections (e.g. 
locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-approved 
research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password protection, 
using chain-of-custody procedures, etc.) 
☒   All electronic communication with participants will comply with Mass General Brigham secure 
communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking identifiers 
with coded data or specimens will be limited to the minimal necessary members of the research 
team required to conduct the research 

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☒ All staff are trained on and will follow the Mass General Brigham policies and procedures for 
maintaining appropriate confidentiality of research data and specimens 
☒ The PI will ensure that all staff implement and follow any Research Information Service Office 
(RISO) requirements for this research 
☒ Additional privacy and/or confidentiality protections 
 
 
Each enrolled subject will have a study ID substituted for names and MRNs 
and no identifiers will be included on their paperwork or electronic study 
record. All electronic data will be stored on Partners built computers 
updated with the latest anti-virus software and stored in locked offices on 
the BWH campus. 
 
 
12.   References 
 
1.  
Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the 
erectile function domain of the international index of erectile function scale. Eur Urol. 
2011;60(5):1010-1016. doi:10.1016/j.eururo.2011.07.053 
2.  
PC W. Anatomic radical prostatectomy: evolution of the surgical technique. J Urol. 
1998;160(6 Pt 2):2418-2424. doi:10.1097/00005392-199812020-00010 
3.  
Montorsi F, Brock G, Stolzenburg J, et al. Effects of Tadalafil Treatment on Erectile 
Function Recovery Following Bilateral Nerve-sparing Radical Prostatectomy : A 
Randomised Placebo-controlled Study ( REACTT ). 2014;65:587-596. 
doi:10.1016/j.eururo.2013.09.051 
4.  
Capogrosso P, Vertosick EA, Benfante NE, et al. Are We Improving Erectile Function 
Recovery After Radical Prostatectomy ? Analysis of Patients Treated over the Last 
Decade. Eur Urol. 2018;75(2):221-228. doi:10.1016/j.eururo.2018.08.039 
5.  
Futura Medical Developments L. A phase III, dose-ranging, multi-centre, randomized, 
doubleblind, placebo-controlled, home use, parallel group clinical trial of topically-applied 
glyceryle trinitrate (GTN) for the treatment of erectile dysfunction (ED), with an open label 
extension. Fut. 2020. 
6.  
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international 
index of erectile function (IIEF): a multidimensional scale for assessment of erectile 
dysfunction. Urology. 1997;49(6):822-830. http://www.ncbi.nlm.nih.gov/pubmed/9187685. 
Accessed March 16, 2016. 
7.  
Rosen RC, Cappelleri JC, Gendrano N. The International Index of Erectile Function 
(IIEF): a state-of-the-science review. Int J Impot Res. 2002;14(4):226-244. 
doi:10.1038/sj.ijir.3900857 
8.  
JC C, RC R, MD S, A M, IH O. Diagnostic evaluation of the erectile function domain of 
the International Index of Erectile Function. Urology. 1999;54(2):346-351. 
doi:10.1016/S0090-4295(99)00099-0 
9.  
Cappelleri JC, Althof SE, Siegel RL, Shpilsky A, Bell SS, Duttagupta S. Development and 
validation of the Self-Esteem and Relationship (SEAR) questionnaire in erectile 
dysfunction. Int J Impot Res. 2004;16(1):30-38. doi:10.1038/sj.ijir.3901095 
10.  
Szymanski KM, Wei JT, Dunn RL, Sanda MG. Development and validation of an 
abbreviated version of the expanded prostate cancer index composite instrument for 
measuring health-related quality of life among prostate cancer survivors. Urology. 
2010;76(5):1245-1250. doi:10.1016/j.urology.2010.01.027 
11.  
Ted A. Skolarus1, 2, 3, Rodney L. Dunn1, Martin G. Sanda4, Peter Chang5, Thomas K. 

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Greenfield6, Mark S. Litwin7, John T. Wei1  and the PC. Minimally Important Difference 
for the Expanded Prostate Cancer Index Composite Short Form. Urology. 
2015;85(1):101-106. doi:10.1016/j.urology.2014.08.044.Minimally 
12.  
Fisher WA, Gruenwald I, Jannini EA, et al. Standards for Clinical Trials in Male and 
Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual 
Dysfunction. J Sex Med. 2017;14(1):3-18. doi:10.1016/j.jsxm.2016.08.016 
 
   
 
 

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APPENDICES 
 
APPENDIX 1 
 
 

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APPENDIX 2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Mass General Brigham Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
Version 2023.06.08   
Page 34 of 34