Clinical Trials/NCT02718378

NCT02718378

Completed

Phase 1

A Phase I, Double-blind, Randomised, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Dosages of Estetrol in Healthy Men

Pantarhei Oncology B.V.1 site in 1 country45 target enrollmentMarch 2016

ConditionsProstatic Neoplasms

Interventionsplacebo estetrol

Drugsestetrol placebo

Overview

Phase: Phase 1
Intervention: placebo
Conditions: Prostatic Neoplasms
Sponsor: Pantarhei Oncology B.V.
Enrollment: 45
Locations: 1
Primary Endpoint: Number of participants with Adverse Events (AEs)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The current study is designed as a phase Ib multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of E4 in healthy men after daily oral administration for 28 days.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

February 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Pantarhei Oncology B.V.

Responsible Party

Sponsor

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;

Arms & Interventions

No added active

placebo without estetrol

Intervention: placebo

estetrol dose level 1

estetrol given in dose level 1

Intervention: estetrol

estetrol dose level 2

estetrol given in dose level 2

Intervention: estetrol

estetrol dose level 3

estetrol given in dose level 3

Intervention: estetrol

Outcomes

Primary Outcomes

Number of participants with Adverse Events (AEs)

Time Frame: 28 days

Changes from baseline measurements considered clinically significant by the Investigator will be reported as AEs.

Change from baseline in hormone levels

Time Frame: 28 days

The serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH), Estradiol (E2), total testosterone and free testosterone levels (actual values as well as percentage change from pre-dose concentration) will be listed and summarized descriptively by treatment group.