Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163033
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
2005-09-12
Brief Title:
Study to Evaluate 3 Dosages of Estetrol After 28 Days Administration in Healthy Postmenopausal Women
Sponsor:
Pantarhei Bioscience
Organization:
Pantarhei Bioscience
Study Overview
Official Title:
Phase I Study to Evaluate the Safety Tolerability PK and Pharmacodynamics of 3 Dosages of Estetrol the Lowest Dose of 2 mg Estetrol Compared With 2 mg of E2 After Daily Oral Administration for 28 Days in Healthy Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This is a partly randomized open-label study in healthy postmenopausal women Groups are treated in the following sequence first a 2 mg estetrol group together with a 2 mg estradiol group When the dose of 2 mg estetrol is safe and the tolerability is good a next higher dose group of estetrol will start possibly followed by two next higher dose groups if the previous dose group is safe and the tolerability is good
The primary objective of this study is to investigate the safety and tolerability of estetrol during multiple dosing for 28 days Furthermore steady state pharmacokinetics and some pharmacodynamic parameters of estetrol will be investigated In addition the pharmacokinetics and pharmacodynamic effects of the 2 mg estetrol group will be compared with those of the 2 mg estradiol group
In each group 5 postmenopausal women will be included with 50 hot flushes per week and 5 postmenopausal women with 10 hot flushes per week These criteria are set to get a more homologous composition in each group
The primary objective of this study is to investigate the safety and tolerability of estetrol during multiple dosing for 28 days Furthermore steady state pharmacokinetics and some pharmacodynamic parameters of estetrol will be investigated In addition the pharmacokinetics and pharmacodynamic effects of the 2 mg estetrol group will be compared with those of the 2 mg estradiol group
In each group 5 postmenopausal women will be included with 50 hot flushes per week and 5 postmenopausal women with 10 hot flushes per week These criteria are set to get a more homologous composition in each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None