Study to Evaluate 3 Dosages of Estetrol After 28 Days Administration in Healthy Postmenopausal Women
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- safety of estetrol
- tolerability of estetrol
- steady state pharmacokinetics of estetrol
- pharmacodynamic effects of estetrol
- to compare the pharmacokinetics and pharmacodynamic effects of 2 mg estetrol with 2 mg estradiol
- to investigate the effect on the number of hot flushes and sweating of 2 mg estetrol compared with 2 mg estradiol
|Study Start Date:||June 2005|
|Study Completion Date:||September 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.