Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT04757532
Eligibility Criteria:
Inclusion Criteria:
* Male volunteers aged between 18 and 50 years.
* Able to understand and accept the trial procedures and able to sign an informed consent.
* History and physical examination that demonstrate not presenting organic or psychiatric disorders.
* ECG, blood and urine tests performed before the experimental session within normal limits. Minor or occasional variations of these limits will be allowed if, in the opinion of the Principal Investigator and taking into account the state of science, they have no clinical significance, do not pose a risk to the subject and do not interfere in the product evaluation. These variations and their non-relevance will be specifically justified in writing.
* Body mass index (weight/height\^2) between 19 and 27 kg/m2 and weight between 50 and 100 kg. BMI of 27-28 kg/m2 may be included according to Principal Investigator's criteria.
Exclusion Criteria:
* Failure to meet inclusion criteria.
* History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or any of the excipients. Lactose intolerance. Serious adverse reactions to any drug.
* Contraindications to treatment with study drugs (according to the respective summary of product characteristics, SmPC). Especially history or presence of breast cancer, liver cancer, and suspected or confirmed prostate carcinoma.
* History or current presence of prostate syndrome symptoms: frequent urination (both day and night), difficulty in starting urination, weak or discontinuous urinary stream, feeling of incomplete bladder emptying, or benign prostatic hyperplasia diagnosis.
* Levels of prostate specific antigen (PSA) out of normal range for subject's age, in those receiving anastrozole, testosterone or danazol.
* Clinical background or evidence of gastrointestinal, hepatic, renal disorder or others that may involve an alteration of the absorption, distribution, metabolism or excretion of the drug.
* Clinical background or evidence of psychiatric disorders, alcoholism, drug abuse or habitual consumption of psychoactive drugs.
* Having participated in another clinical trial with medication in the three months prior to the start of the study.
* Having suffered some organic disease or major surgery in the six months prior to the start of the study.
* Clinical background or evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, dermatological or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by him/her, may pose a risk to the subjects or may interfere with the objectives of the study. Especially history of venous thrombosis or thromboembolic disorders, thrombophilic alteration, edema, hypercalcemia, polycythemia, nephrosis, liver disease with altered liver function tests and porphyria.
* Having taken medication regularly in the month prior to the study sessions, including vitamins, herbal remedies or dietary supplements. Treatment with a single dose of symptomatic medication in the week prior to the study sessions will not be a reason for exclusion if it is assumed that the drug has been completely eliminated on the day of the experimental session.
* Smokers of more than 20 cigarettes a day in the 3 months before the study.
* Consumption of more than 40 g of alcohol daily.
* Consumers of more than 5 coffees, teas, cola drinks, or other stimulant drinks or with xanthines daily in the 3 months prior to the study start.
* Being unable to understand the nature, consequences of the trial and the procedures that are asked to follow.
* Positive serology for hepatitis B, C or HIV.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04757532
Study Brief:
Protocol Section:
NCT04757532