Prostate cancer
Conditions
Interventions
The study will start with a screening. At the screening a physical examination
will take place and a few other standard medical assessments will be performed
(ECG, vital signs) including prostate pa
Sponsors
Pantarhei Oncology
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Healthy male, age between 40 and 70 years (both inclusive); * Body mass index between *18.5 and *30.0 kg/m2; * Normal prostate-specific antigen (PSA) value (
Exclusion criteria
Exclusion criteria: * Any clinically significant abnormality following review of medical history, laboratory results, physical examination and ECG at screening; * Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of any of the study drugs; * Previous use of steroids within: o 8 weeks for oral preparations o 4 weeks for transdermal preparations o Any time for injections; * No contraindications for steroids or estetrol use; * Prostate hyperplasia or micturition problems that suggest the presence of prostate hyperplasia (micturition problems are defined as a score of >7 based on the International Prostate Symptom Score (I-PSS) questionnaire); * Presence of an active acute or chronic infection, including syphilis, HIV or viral hepatitis B and/or C (or previously treated);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Pharmacodynamics, Pharmacokinetics, Randomised | — |
Countries
Netherlands
Outcome results
None listed