Effectiveness and safety of combined autologous Platelet Rich Plasma and Focal Shockwave Therapy for the treatment of erectile dysfunction

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boston Medical Group Spain S.L.

Participant type

Patients

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

19 Aug 2024 → ongoing

Decision date (initial)

2024-08-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Boston Medical Group Spain · CDTI-E.P.E.

External identifiers

EU CT number

2024-517248-73-00

EudraCT number

2022-002985-34

ClinicalTrials.gov

NCT06433596

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate 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 the IIEF-EF questionnaire score after 12 weeks of treatment completion.

Secondary objectives 3

1. To evaluate 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.
2. To evaluate 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.
3. To evaluate the safety of intracavernous autologous platelet-rich plasma therapy, alone and combined with shock wave therapy, for the treatment of moderate or mild to moderate erectile dysfunction.

Conditions and MedDRA coding

Erectile dysfunction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

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

Exclusion criteria 1

1. 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 (positive ADAM). 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 anatomic 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 treatment with medications (antiandrogen therapy, alpha blockers for BPH, use of corticosteroids, antiparkinsonian drugs, antipsychotics). 16. Patients with erectile dysfunction of psychological origin. 17. Abuse of psychoactive substances (including alcohol). 18. Cognitive or physical illness that prevents the patient from participating in the study, from completing the questionnaires or attending therapies and controls. 19. Inability to attend therapies and controls.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in IIEF-EF score between baseline and week 21

Secondary endpoints 8

1. Change in IIEF-EF score between baseline and week 13
2. Change in IIEF-EF score between baseline and week 33
3. Proportion of patients achieving the minimum clinically meaningful difference in IIEF-EF score (5 points), at weeks 13, 21, and 33
4. Change in EHS score between baseline and measurements at weeks 13, 21, and 33
5. Proportion of patients achieving vaginal penetration after treatment, as assessed by change in EHS from 1 or 2 at baseline to 3 or 4 at weeks 13, 21, and 33
6. Change in Sexual Quality of Life Questionnaire - SLQQ score between baseline and measurements at weeks 13, 21, and 33
7. Change in Global Assessment Questionnaire Score - GA at Weeks 13, 21, and 33
8. Incidence of PRP-related adverse events during the study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boston Medical Group Spain S.L.

Sponsor organisation

Boston Medical Group Spain S.L.

Address

Calle De Velazquez 26 1 Dcha De

City

Madrid

Postcode

28001

Country

Spain

Scientific contact point

Organisation

Boston Medical Group Spain S.L.

Contact name

Elexial Research Center

Public contact point

Organisation

Boston Medical Group Spain S.L.

Contact name

Elexial Research Center

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications