A Phase I, double-blind, randomised, placebo-controlled, multiple dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of two dosages of estetrol in healthy me

Completed

• Conditions: Prostate cancer; 10038597

• Registration Number: NL-OMON43503
• Lead Sponsor: Pantarhei Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

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 (< 3.0 ng/mL);

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);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety, efficacy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety, Pharmacodynamics, Pharmacokinetics, Randomised</p><br>