Evaluation of Safety and Efficacy of Estetrol in Healthy Men

Launched by PANTARHEI ONCOLOGY B.V. · Mar 18, 2016

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male, age between 40 and 70 years (both inclusive);
• • Good physical and mental health as judged by the Investigator determined by medical history, physical examination (including prostate palpation), clinical laboratory, vital signs and ECG recording;
• • Body mass index between ≥ 18.5 and ≤ 30.0 kg/m2;
• • Normal prostate-specific antigen (PSA) value (\< 3.0 ng/mL);
• • Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study medication. Men who have been vasectomized less than 4 months prior to study start must follow the same restrictions as non-vasectomized men;
• • Men must agree not to donate sperm from the first dose until 90 days after the last dose;
• • Ability to communicate well with the Investigator and to comply with the requirements of the entire study;
• • Willing to give informed consent in writing.
• Exclusion Criteria:
• • Any clinically significant abnormality following review of medical history, laboratory results, physical examination and ECG at screening as judged by the Investigator;
• • Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of any of the study drugs;
• * Previous use of steroids within:
• • 8 weeks for oral preparations
• • 4 weeks for transdermal preparations
• • Any time for injections;
• • Contraindications for steroids or estetrol;
• • Prostate hyperplasia or micturition problems that suggest the presence of prostate hyperplasia;
• • Presence of an active acute or chronic infection, including syphilis, HIV or viral hepatitis B and/or C (or previously treated);
• • Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication before screening;
• • Hypersensitivity to the active substances or to any of the excipients of the investigational product or placebo therapy;
• • Use of probiotics (as present in dairy products, fortified foods etc.) during the 3 months before screening and during the clinical study;
• * Use of one or more of the following medications:
• • Antihypertensive drugs
• • Present use or use within 30 days before the start of the study drug of the following drugs: aprepitant, bosentan, armodafinil, phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, glucocorticoids, topiramate, felbamate, rifampicin, clobazamechinacea; vemurafenib, non-nucleoside reverse transcriptase inhibitors, griseofulvin, ketoconazole, and herbal remedies containing Hypericum perforatum
• • Any medication (including over-the-counter products) within 14 days before first dosing except for occasional non-steroidal anti-inflammatory drugs (NSAIDs; e.g. ibuprofen); paracetamol is not permitted
• • Use of antibiotics;
• • Administration of any other investigational drug within 3 months before first dosing;
• • Loss of more than 400 mL blood during the 3 months before screening, e.g. as a blood donor, or intention to donate blood in the 3 months after completing the study;
• * Subjects with a history of (within 12 months) alcohol or drug abuse or with a positive result at screening, for tests of:
• • alcohol intake
• • drug abuse;
• • Currently smoking or smoked within the last 6 months before screening.