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Study to Evaluate 3 Dosages of Estetrol After 28 Days Administration in Healthy Postmenopausal Women

NCT00163033 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-05-21

No results posted yet for this study

Summary

Estetrol is a natural compound that is produced by the fetus during fetal life and circulates in the unborn child and the mother. It is an estrogenic compound. In this study the safety and tolerability of 28 days of the oral administration of estetrol in healthy postmenopausal women are investigated. In addition, the pharmacokinetics and some pharmacodynamic parameters are studied. The lowest dose of 2 mg estetrol is directly compared with 2 mg estradiol.

Conditions

  • Healthy

Interventions

DRUG

estetrol

Sponsors & Collaborators

  • Pantarhei Bioscience

    lead INDUSTRY

Principal Investigators

  • Herjan Coelingh Bennink, MD, PhD · Pantarhei Bioscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2007-08-31
Completion
2007-09-30

Countries

  • Netherlands

Study Locations

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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 NCT00163033 on ClinicalTrials.gov