Prostatic intraepithelial neoplasia (PIN)
Conditions
Interventions
1:Infemin in the initial dose of 900 mg of DIM a day (3 capsules 2 times a day)
2:placebo (3 capsules 2 times a day)
Sponsors
CJSC “IlmixGroup”
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. histologically verified diagnosis of high grade prostatic intraepithelial neoplasia (PIN); 2. residual urine volume =5 mL/s; 5. ability to perform the procedures provided for the study protocol; 6. no dependence on the persons involved in research and interested in its outcome; 7. a written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. alcohol or drug abuse; 2. malignant tumors of any localization; 3. acute urine retention, neurogenic dysfunctions and bladder ears, 4. urethral stricture, bladder neck sclerosis, urinary infections in a phase of active inflammation 5. history of surgical interventions on pelvic organs or their planning in the nearest 12 months; 6. treatment of chronic prostatitis within 1 month before the first study dose and treatment of prostatic hyperplasia or PIN within 3 months before the first study dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A statistically significant decrease of morphological index (MI) comparing to placebo; | — |
Secondary
| Measure | Time frame |
|---|---|
| A proportion of the patients with persistent PIN/BPH in 12 months after the Infemin therapy start; | — |
Countries
Russia
Contacts
Public ContactAndrey Kaprin
Outcome results
None listed