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Sponsored by: |
Pantarhei Bioscience |
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Information provided by: | Pantarhei Bioscience |
ClinicalTrials.gov Identifier: | NCT00163033 |
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.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: estetrol |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | August 2007 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Previous use of estrogen/progestogen within:
Contraindications for using steroids:
Contact: Monique Visser, PhD | +31 30 6985024 | mv@pantarheibio.com |
Netherlands | |
Kendle Clinical Pharmacology Unit | Recruiting |
Utrecht, Netherlands, 3584 CJ | |
Contact: Floris Hoppener, MD +31 30 2584500 hoppener.floris@kendle.com | |
Principal Investigator: Floris Hoppener, MD |
Study Director: | Herjan Coelingh Bennink, MD, PhD | Pantarhei Bioscience |
Study ID Numbers: | PR3054 |
Study First Received: | September 12, 2005 |
Last Updated: | March 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00163033 |
Health Authority: | Netherlands: Independent Ethics Committee |
phase I study |
Estradiol 3-benzoate Estradiol valerate Estradiol 17 beta-cypionate |
Healthy Polyestradiol phosphate Estradiol |