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Evaluation of Safety and Efficacy of Estetrol in Healthy Men

NCT02718378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-02-09

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

estetrol

DRUG

placebo

Sponsors & Collaborators

  • Pantarhei Oncology B.V.

    lead OTHER

Principal Investigators

  • Tjeert Mensinga, MD, PhD · QPS Netherlands BV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718378 on ClinicalTrials.gov