Clinical Trials Register

Summary
EudraCT Number:	2019-002057-34
Sponsor's Protocol Code Number:	PRePED-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-01-14
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2019-002057-34

A.3

Full title of the trial

A RANDOMISED, DOUBLE-BLIND CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF INTRACAVERNOSAL INFUSION OF PLATELET RICH PLASMA (PRP) AGAINST PLATELET POOR PLASMA (PPP) IN THE TREATMENT OF VASCULOGENIC ERECTILE DYSFUNCTION.

Ensayo doble ciego, controlado y aleatorizado para evaluar la eficacia de la inyección intracavernosa de plasma rico en plaquetas (PRP) frente al plasma pobre en plaquetas (PPP) en el tratamiento de la disfunción eréctil de origen vascular.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

PRePED (PRP in Erectile Dysfunction) study

A.4.1

Sponsor's protocol code number

PRePED-01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fundación de Investigación Biomédica Hospital Puerta de Hierro
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Instituto de Salud Carlos III. Fondos de Investigación Sanitaria
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Servicio de Farmacología Clínica. Hospital Universitario Puerta de Hierro Majadahonda
B.5.2	Functional name of contact point	Gustavo Adolfo Centeno Soto
B.5.3	Address:
B.5.3.1	Street Address	Calle Joaquín Rodrigo 2
B.5.3.2	Town/ city	Majadahonda
B.5.3.3	Post code	28222
B.5.3.4	Country	Spain
B.5.4	Telephone number	34911916481
B.5.5	Fax number	34911917650
B.5.6	E-mail	gustavoadolfo.centeno@salud.madrid.org

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Platelet Rich Plasma
D.3.4	Pharmaceutical form	Concentrate and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracavernous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Platelet rich plasma
D.3.9.3	Other descriptive name	AUTOLOGOUS PLASMA
D.3.9.4	EV Substance Code	SUB117286
D.3.10	Strength
D.3.10.1	Concentration unit	µl microlitre(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	140 to 160
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for injection
D.8.4	Route of administration of the placebo	Intracavernous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate and solvent for solution for injection
D.8.4	Route of administration of the placebo	Intracavernous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Vascular Erectile Dysfunction

Disfunción erectil de origen vascular

E.1.1.1

Medical condition in easily understood language

Erectile dysfunction

E.1.1.2

Therapeutic area

Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10061461
E.1.2	Term	Erectile dysfunction
E.1.2	System Organ Class	10038604 - Reproductive system and breast disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of intracavernous injection of leukodeplected PRP collected by apheresis and stored as platelet lysate in the treatment of vascular erectile dysfunction in comparison to PPP measured by the improved in the IIEF-EF score after 28 weeks.

E.2.2

Secondary objectives of the trial

- To evaluate the clinical safety of intracavernous injection of leukodeplected PRP collected by apheresis and stored as platelet lysate, in the treatment of vascular erectile dysfunction
- To determine the synergic efficacy of leukodeplected PRP collected by apheresis and stored as platelet lysate on the therapeutic response to oral administration of PDE5 inhibitors.
- To analyze the cytokines and growth factors concentration (EGF, FGF-2, IFN gamma, IL-6, IL-10, TNF-alfa, VEGFA, TGF-beta1, IGF-1, PDGF-BB, GDF-11 and IL- 8) in the PRP and PPP of each patient and their relationship with the clinical response to PRP.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects must meet all inclusion criteria to be eligible for study enrollment.
2. Men between 40 and 75 years old, with a relationship of more than 6 months of duration.
3. Erectile dysfunction for at least 6 months with an IIEF-EF (while using the higher tolerated dose of PDE5-Is) between 5 and 16 points, inclusive.
4. Erectile dysfunction of vascular origin. This will be determined by clinical history and pathological intracavernosal vasoactive testing (E0-E3 after 15-30 minutes of ICI of alprostadil 20mcg). In case of doubtful results (E4-E5 after 15-30 minutes of ICI of alprostadil 20mcg), a pathological Doppler ultrasound (PSV <40cm/sec after 15-30 minutes of ICI of alprostadil 20mcg) must be proven. In case of clinical doubt or incongruence, a Nocturnal Penile Tumescence and Rigidity Test (NPTR) will be performed. In this case, criteria inclusion is having no event in the night with a penile rigidity (tip) of ≥70% during ≥5min.
5. Subjects agree to attempt vaginal intercourse at least 4 times every month after the end of the treatment and agree to document the outcome using the Sexual Encounter Profile (SEP) and the Erection Hardness Score (EHS).
6. Commitment not to use other treatment for ED during the study (herbal, topical, intraurethral, intracavernosal, etc).
7. Commitment to completing the rest of the questionnaires and other measurement instruments during the study phase.
8. Willingness and ability to comply with study procedures, other measurements instruments and visit schedules and able to follow oral and written instructions.
9. Signed an ethics committee-reviewed and approved informed consent form.

E.4

Principal exclusion criteria

1. Documented psychogenic erectile dysfunction (with NPTR test: at least one event in the night with a penile rigidity (tip) of ≥70% during ≥5min).
2. Erectile dysfunction of neurogenic origin (radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, diabetes mellitus is not included unless documented diabetic neuropathy).
3. Some other current sexual dysfunction (premature ejaculation, etc.).
4. Prior implant of penile prosthesis or other penile surgeries different to circumcision, frenuloplasty or condyloma removal.
5. Previous history of penile fracture, Peyronie’s disease or priapism.
6. History of radical prostatic or bladder surgery (radical cystectomy or prostatectomy).
7. Previous radiation to pelvis.
8. History of symptomatic hypogonadism (testosterone level <346ng/dl) not treated. If treated hypogonadism, testosterone levels non-stable for at least 3 months.
9. Major hematologic, renal, or hepatic abnormalities.
10. Severe decompensated cardiac and vascular insufficiency, or critical coronary heart disease.
11. Poorly controlled hypertension or diabetes mellitus (HbA1c >12%).
12. Recent (within previous six months of the inclusion) stroke or myocardial infarction.
13. Active peptic ulcer disease
14. Neoplasm of any origin in active treatment or active progression.
15. History of psychiatric pathology (depressive syndrome, schizophrenia, bipolar disorder).
16. History of alcohol abuse (More than 7 alcohol units drink a week or more than 3 per occasion) or drug abuse (any drug consumption different to alcohol or tobacco, used more than three times per month).
17. Treatment with oral anticoagulants (dicoumarin or by-products) or antiandrogens.
18. Active treatment as nitric oxide (NO) donor drugs.
19. Prior positive serology to HBsAg, HCV (by genomic test), HIV-1/2, syphilis.
20. Thrombopenia less than 100 x 109 / L.
21. Anemia (Hemoglobin <13 g/dl).
22. Poor venous access or any other circumstance (e.g. virological results) that preclude an apheresis procedure.
23. Lack of sexual practices in recent months (less than 4 attempts in the last three months).
24. Lack of commitment on the part of the patient to attend the tests requested.

E.5 End points

E.5.1

Primary end point(s)

The main planned analysis will compare difference increments between both treatment groups (referred to our study as PRP V9(PT) IIEF-EF- V3IIEF-EF vs PPP V9(PT)IIEF-EF - V3IIEF-EF) after 4 weeks of the end of the treatment.

E.5.1.1

Timepoint(s) of evaluation of this end point

9 weeks

E.5.2

Secondary end point(s)

1. The adverse events incidence related to apheresis and PRP and PPP infusion during the study period.
2. The percentage of patients in each group who achieve a minimal clinical difference (5 or 7 points, depending of baseline grade of ED, in the IIEF-EF between V9(PT) and V3.
3. The percentage of patients in each group who achieve a minimal clinical difference (5 or 7 points in the IIEF-EF between V10 and V1-baseline) at 8 weeks after the end of the treatment.
4. The percentage of patients in each group who achieve a minimal clinical difference (5 or 7 points in the IIEF-EF between V11a and V3) at 16 weeks after the end of the treatment.
5. The percentage of patients in each group who achieve a minimal clinical difference (5 or 7 points in the IIEF-EF between V12a and V3) at 28 weeks after the end of the treatment.
6. The change of the other domains of IIEF questionnaire (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction) from baseline to 4, 8 (V10 vs V1), 16 and 28 weeks after the end of the treatment.
7. The change of the Global Assessment Questionnaire (GAQ 1 and 2) from baseline to 4, 8 (V10 vs V1), 16 and 28 weeks after the end of the treatment.
8. The change of the Sexual Encounter Profile Questions 2 and 3 (SEP 2 and SEP3, MCID=21.4% and 23%, respectively)) from baseline to 4, 8 (V10 vs V1), 16 and 28 weeks after the end of the treatment.
9. The percentage of patients who achieve MCID in the Erection Hardness Score (EHS, MCID=1) from baseline to 4, 8 (V10 vs V1), 16 and 28 weeks after the end of the treatment.
10. The change of the Peak Systolic Velocity (PSV) of the cavernosal arteries from baseline to 28 weeks after the end of the treatment.
11. The percentage of patients who achieve a positive intracavernosal vasoactive test from baseline to 28 weeks after the end of the treatment.
12. The difference between the two groups in the change of the girth and length of the stretched flaccid and erected penis from baseline to 28 weeks after the end of the treatment.
13. The difference of the placebo response between Visit 3 and Visit 1 of all the patients (V3 IIEF-EF- V1 IIEF-EF)
14. To explore the relationship between cytokines and growth factors concentration (EGF, FGF-2, IFN gamma, IL-6, IL-10, TNF-alpha, VEGFA, TGF-beta 1, IGF-1, PDGF-BB, GDF-11 and IL- 8) and IIEF-EF changes from baseline to 4, 8 (V10 vs V1), 16 and 28 weeks after the end of the treatment.

E.5.2.1

Timepoint(s) of evaluation of this end point

60 weeks

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Platelet Poor Plasma

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit of the last subject

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

The patient will receive the best treatment available for the erectile dysfunction that the principal investigator considers the most appropriate for ED, but the patient may not be able to continue administering the study medication.
Therefore, neither the researcher nor the promoter acquire any commitment to maintain such treatment outside of this study.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-02-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-01-22

P. End of Trial
P.	End of Trial Status	Ongoing

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