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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris French Health Products Safety Agency FRM Solvay Pharmaceuticals |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00236301 |
Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.
Condition | Intervention | Phase |
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Healthy Symptomatic Menopausal Women |
Drug: CLIMASTON (drug) Drug: 17 Beta-estradiol (2mg/day)and (1mg/day) Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women |
Enrollment: | 99 |
Study Start Date: | March 2004 |
Study Completion Date: | January 2007 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
17 Beta-estradiol (2mg/day)and (1mg/day)
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Drug: 17 Beta-estradiol (2mg/day)and (1mg/day)
17 Beta-estradiol (2mg/day)and (1mg/day)
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2: Active Comparator
CLIMASTON
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Drug: CLIMASTON (drug)
CLIMASTON(drug)
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3: Placebo Comparator
placebo
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Drug: placebo
placebo
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Pro-inflammatory study of the effects in short term of two difference doses of 17beta-estradiol at the menopause woman
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
CIC, Saint Antoine Hospital | |
Paris cedex 12, France, 75571 |
Principal Investigator: | Tabassome Simon, M.D., Ph.D. | Service de Pharmacologie (Pr Jaillon) CHU Saint-Antoine 27, rue de Chaligny, 75012 Paris |
Responsible Party: | Department Clinical Research of Developement ( Yannick Vacher ) |
Study ID Numbers: | P021204 |
Study First Received: | October 11, 2005 |
Last Updated: | January 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00236301 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Hormone Menopause Inflammation Dose effects Apoptosis |
Progesterone Benzoates Estradiol 3-benzoate Estradiol valerate Estradiol 17 beta-cypionate |
Healthy Polyestradiol phosphate Estradiol Menopause Inflammation |
Estrogens Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs Contraceptive Agents, Female |
Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Pharmacologic Actions |