Clinical Trials Register

Summary
EudraCT Number:	2022-002985-34
Sponsor's Protocol Code Number:	03
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:	2022-09-23
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

2022-002985-34

A.3

Full title of the trial

EFFECTIVENESS AND SAFETY OF COMBINED AUTOLOGOUS PLATELET RICH
PLASMA AND FOCAL SHOCKWAVE THERAPY FOR THE TREATMENT OF
ERECTILE DYSFUNCTION

EFECTIVIDAD Y SEGURIDAD DE LA TERAPIA COMBINADA DE PLASMA RICO
EN PLAQUETAS AUTÓLOGO Y ONDAS DE CHOQUE FOCALES PARA EL
TRATAMIENTO DE LA DISFUNCIÓN ERÉCTIL

A.3.1

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

PRP and focal waves for the treatment of erectile dysfunction

PRP y ondas focales para el tratamiento de la disfunción eréctil

A.4.1

Sponsor's protocol code number

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	Boston Medical Group
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	Boston Medical Group
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	Boston Medical Group
B.5.2	Functional name of contact point	José Benitez Molina
B.5.3	Address:
B.5.3.1	Street Address	Paseo de la Castellana 93 séptima planta
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28046
B.5.3.4	Country	Spain
B.5.4	Telephone number	34607769225
B.5.6	E-mail	jbenitez@boston.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	PRP - RegenKit®-BCT-3 Plus
D.3.2	Product code	-
D.3.4	Pharmaceutical form	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	PRP - RegenKit®-BCT-3 Plus
D.3.9.3	Other descriptive name	Autologous platelet rich plasma and blood cells, peripheral blood-derived
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	Yes
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	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

Moderate or mild to moderate erectile dysfunction.

Disfunción eréctil moderada o leve a moderada.

E.1.1.1

Medical condition in easily understood language

sexual impotence

Impotencia sexual

E.1.1.2

Therapeutic area

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

MedDRA Classification

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 assess the effectiveness of intracavernous autologous platelet-rich plasma therapy, compared with placebo, for the treatment of moderate or mild-to-moderate erectile dysfunction, measured as improvement in IIEF-EF questionnaire score after 12 weeks from the end of the treatment.

Evaluar la efectividad de la terapia intracavernosa de plasma rico en plaquetas autólogo, en comparación con placebo, para el tratamiento de la disfunción eréctil moderada o leve a moderada, medida como mejoría en el puntaje del cuestionario IIEF-EF después de 12 semanas de finalizado el tratamiento.

E.2.2

Secondary objectives of the trial

To assess the effectiveness of intracavernous autologous platelet-rich plasma therapy for the treatment of moderate or mild to moderate erectile dysfunction, at 4, 12 and 24 weeks after the end of treatment (1 and 6 months of follow-up).

To assess the effectiveness of intracavernous autologous platelet-rich plasma therapy combined with focal shock wave therapy, for the treatment of moderate or mild to moderate erectile dysfunction, at 4, 12 and 24 weeks after the end of treatment (1, 3 and 6 month follow-up).

To assess the clinical safety of intracavernous autologous platelet-rich plasma therapy, alone and in combination with shock wave therapy, for the treatment of moderate or mild to moderate erectile dysfunction.

Evaluar la efectividad de la terapia intracavernosa de plasma rico en plaquetas autólogo para el tratamiento de la disfunción eréctil moderada o leve a moderada, a las 4,12 y 24 semanas de finalizado el tratamiento (1 y 6 meses de seguimiento).

Evaluar la efectividad de la terapia intracavernosa de plasma rico en plaquetas autólogo combinado con terapia de ondas de choque focales, para el tratamiento de la disfunción eréctil moderada o leve a moderada, a las 4,12 y 24 semanas de finalizado el tratamiento (1, 3 y 6 meses de seguimiento).

Evaluar la seguridad clínica de la terapia intracavernosa de plasma rico en plaquetas autólogo, solo y combinado con terapia de ondas de choque, para el tratamiento de la disfunción eréctil moderada o leve a moderada.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men over 18 years old.
2. Erectile dysfunction present for more than 3 months in more than 50% of coitus.
3. Baseline score of the IIEF-EF questionnaire between 11 and 21.
4. Stable heterosexual relationship of at least 6 months.
5.Commitment to have at least 3 vaginal intercourse per month after treatment ends.
6.Commitment not to use other natural, oral or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion.
7.Patient who agrees to enter the study voluntarily by signing an informed consent.

1. Hombres mayores de 18 años.
2. Disfunción eréctil presente hace más de 3 meses en más del 50% de los coitos.
3. Puntaje basal del cuestionario IIEF-EF entre 11 y 21.
4. Relación heterosexual estable de al menos 6 meses.
5. Compromiso de tener al menos 3 relaciones sexuales vaginales por mes después de terminado el tratamiento.
6. Compromiso de no usar otros tratamientos naturales, farmacológicos orales o intracavernosos durante el tratamiento y hasta 6 meses de finalizado este.
7. Paciente que acepta entrar voluntariamente al estudio a través de la firma de un consentimiento informado.

E.4

Principal exclusion criteria

1. Score of 4 on the EHS scale.
2. Patients with INR greater than 3.
3. Patients with sickle cell anemia.
4. Patients with clinical suspicion of hypogonadism (ADAM positive).
5. Acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency.
6. Active bladder, prostate or colon cancer.
7. Radical prostatectomy or other radical pelvic surgery.
8. History of pelvic radiotherapy.
9. Spinal cord injury or other neurological disease associated with ED.
10. Penile anatomical dysfunction, penile implant.
11. Platelet diseases or coagulation disorders.
12. Treatment with oral anticoagulants.
13. Platelet count outside the normal range (150 to 400 × 109/L).
14. Patients with active infections or lesions of the penis or pubic area.
15. Patients with erectile dysfunction secondary to drug treatment (antiandrogenic therapy, Alpha blockers for BPH, use of corticosteroids, antiparkinsonians, antipsychotics).
16. Patients with erectile dysfunction of psychological origin.
17. Abuse of psychoactive substances (including alcohol).
18. Cognitive or physical illness that prevents you from participating in the study, self-completing the questionnaires or attending therapies and controls.
19. Inability to attend therapies and controls.

1. Puntaje de 4 en la escala EHS.
2. Pacientes con INR mayor a 3.
3. Pacientes con anemia de células falciformes.
4. Pacientes con sospecha clínica de hipogonadismo (ADAM positivo).
5. Acromegalia, gigantismo, enfermedad de Addison, hiperprolactinemia, deficiencia androgénica.
6. Cáncer vesical, de próstata o colon activo.
7. Prostatectomía radical u otra cirugía pélvica radical.
8. Antecedentes de radioterapia pélvica.
9. Lesión raquimedular u otra enfermedad neurológica asociada a DE.
10. Disfunción anatómica peneana, implante de pene.
11. Enfermedades plaquetarias o trastornos de la coagulación.
12. Tratamiento con anticoagulantes orales.
13. Conteo de plaquetas fuera del rango normal (150 a 400 × 109/L).
14. Pacientes con infecciones o lesiones activas del pene o la zona púbica.
15. Pacientes con disfunción eréctil secundaria a tratamiento con medicamentos (terapia antiandrogénica, Alfa bloqueadores para HPB, uso de corticosteroides, antiparkinsonianos, antipsicóticos).
16. Pacientes con disfunción eréctil de origen psicológico.
17. Abuso de sustancias psicoactivas (incluyendo alcohol).
18. Enfermedad cognitiva o física que le impida participar en el estudio, auto rellenar los cuestionarios o asistir a las terapias y controles.
19. Incapacidad para asistir a las terapias y controles.

E.5 End points

E.5.1

Primary end point(s)

Change in IIEF-EF score between the baseline measurement and the measurement at week 21 (3 months after the end of treatment).

Cambio en el puntaje de IIEF-EF entre la medida basal y la medida en la semana 21 (3 meses después de finalizado el tratamiento).

E.5.1.1

Timepoint(s) of evaluation of this end point

week 21 (3 months after the end of treatment).

21 semanas )3 meses posterior al tratamiento)

E.5.2

Secondary end point(s)

- Change in IIEF-EF score between baseline measurement and measurement at week 13 (1-month follow-up)
- Change in IIEF-EF score between baseline measurement and measurement at week 33 (6-month follow-up)
- Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points), at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up).
- Change in EHS score between the baseline measurement and the measurement at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up).
- Proportion of patients who achieve penetration after treatment, evaluated by the change in EHS from 1 or 2 at baseline to 3 or 4 at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up).
- Change in the score of the sexual quality of life questionnaire - SLQQ between the baseline measurement and the measurement at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up).
- Change in global assessment questionnaire score - CGA at weeks 13, 21 and 33 (1, 3 and 6 months of follow-up).
- Incidence of adverse events related to PRP during the study.

- Cambio en el puntaje de IIEF-EF entre la medida basal y la medida en la semana 13 (1 mes de seguimiento)
- Cambio en el puntaje de IIEF-EF entre la medida basal y la medida en la semana 33 (6 meses de seguimiento)
- Proporción de pacientes que logran la diferencia mínima clínicamente significativa en el puntaje del IIEF-EF (5 puntos), en las semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento).
- Cambio en el puntaje EHS entre la medida basal y la medida en las semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento).
- Proporción de pacientes que logran penetrar posterior al tratamiento, evaluado por el cambio en el EHS al pasar de 1 o 2 a nivel basal a 3 o 4 en las semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento).
- Cambio en el puntaje del cuestionario de calidad de vida sexual - SLQQ entre la medida basal y la medida en las semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento).
- Cambio en el puntaje del cuestionario de evaluación global - CGA en las semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento).
- Incidencia de eventos adversos relacionados con el PRP durante el estudio.

E.5.2.1

Timepoint(s) of evaluation of this end point

- week 13 (1-month follow-up)
- week 33 (6-month follow-up)
- weeks 13, 21 and 33 (1, 3 and 6 months of follow-up)
- weeks 13, 21 and 33 (1, 3 and 6 months of follow-up)
- weeks 13, 21 and 33 (1, 3 and 6 months of follow-up)
- weeks 13, 21 and 33 (1, 3 and 6 months of follow-up)
- weeks 13, 21 and 33 (1, 3 and 6 months of follow-up)

-semana 13 (1 mes de seguimiento)
-semana 33 (6 meses de seguimiento)
-semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento)
-semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento)
-semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento)
-semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento)
-semanas 13, 21 y 33 (1, 3 y 6 meses de seguimiento).

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

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

Boston Medical Group (BMG) correspond to a men health specialized global alliance of medical centers in different countries. Erectile disfunction research is one of is aims, looking for scientific evidence that enhance erectile disfunction diagnosis and treatment, improving affected men health.

Boston Medical Group (BMG) es una alianza global de centros médicos especializados en salud sexual masculina en diferentes países del mundo. Entre sus objetivos está realizar investigación primaria en disfunción eréctil con el propósito de determinar evidencia científica para mejorar el diagnóstico y manejo de la disfunción, impactando en los desenlaces de salud de los hombres con esta condición.

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)

expected normal treatment of that condition

Tratamiento normal esperado de esa condición

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

2023-09-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-08-25

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

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