Study to Evaluate 3 Dosages of Estetrol After 28 Days Administration in Healthy Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT00163033|
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: estetrol||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2005|
|Primary Completion Date :||August 2007|
|Study Completion Date :||September 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163033
|Kendle Clinical Pharmacology Unit|
|Utrecht, Netherlands, 3584 CJ|
|Study Director:||Herjan Coelingh Bennink, MD, PhD||Pantarhei Bioscience|