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Tracking Information | |||||
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First Received Date † | September 12, 2005 | ||||
Last Updated Date | March 1, 2007 | ||||
Start Date † | June 2005 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00163033 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Study to Evaluate 3 Dosages of Estetrol After 28 Days Administration in Healthy Postmenopausal Women | ||||
Official Title † | A Phase I, Partly Randomized, Open-Label, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estetrol, the Lowest Dose of 2 mg Estetrol Compared With 2 mg of Estradiol, After Daily Oral Administration for 28 Days in Healthy Postmenopausal Women | ||||
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. |
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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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study | ||||
Condition † | Healthy | ||||
Intervention † | Drug: estetrol | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 40 | ||||
Completion Date | August 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | Netherlands | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00163033 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Pantarhei Bioscience | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Pantarhei Bioscience | ||||
Verification Date | March 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |