platelet concentrate for Erectile dysfunction

Inclusion criteria

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

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Change in IIEF-EF score between baseline and week 21","definition_or_measurement_approach":"Measured as change in IIEF-EF (International Index of Erectile Function - Erectile Function domain) score between baseline and week 21 using the IIEF-EF questionnaire."}

Secondary endpoints

• {"endpoint_text":"- Change in IIEF-EF score between baseline and week 13","definition_or_measurement_approach":"Measured as change in IIEF-EF score between baseline and week 13 using the IIEF-EF questionnaire."}
• {"endpoint_text":"- Change in IIEF-EF score between baseline and week 33","definition_or_measurement_approach":"Measured as change in IIEF-EF score between baseline and week 33 using the IIEF-EF questionnaire."}
• {"endpoint_text":"- Proportion of patients achieving the minimum clinically meaningful difference in IIEF-EF score (5 points), at weeks 13, 21, and 33","definition_or_measurement_approach":"Proportion achieving ≥5-point improvement in IIEF-EF at weeks 13, 21, and 33."}
• {"endpoint_text":"- Change in EHS score between baseline and measurements at weeks 13, 21, and 33","definition_or_measurement_approach":"Change in Erection Hardness Score (EHS) between baseline and weeks 13, 21 and 33."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion with EHS change from 1/2 to 3/4 at weeks 13, 21, and 33 indicating ability to achieve vaginal penetration."}
• {"endpoint_text":"- Change in Sexual Quality of Life Questionnaire - SLQQ score between baseline and measurements at weeks 13, 21, and 33","definition_or_measurement_approach":"Change in SLQQ (Sexual Quality of Life Questionnaire) scores at specified timepoints."}
• {"endpoint_text":"- Change in Global Assessment Questionnaire Score - GA at Weeks 13, 21, and 33","definition_or_measurement_approach":"Change in global assessment questionnaire score at weeks 13, 21, and 33."}
• {"endpoint_text":"- Incidence of PRP-related adverse events during the study.","definition_or_measurement_approach":"Collection and reporting of adverse events considered related to platelet-rich plasma treatment during the study period."}

Spain

Earliest CTIS Part Ii Submission Date

12-08-2024

Latest Decision Or Authorization Date

19-08-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

116

Primary sponsor

Full Name

Boston Medical Group Spain S.L.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Boston Medical Group Spain","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"CDTI-E.P.E.","duties_or_roles":"Source of monetary support","organisation_type":""}