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Sponsored by: |
University Hospital, Toulouse |
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Information provided by: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT00701337 |
The aim of this pilot study conducted in post-menopausal women is to evaluate the effect of 17ß-estradiol administration on inflammatory-immune cells, namely antigen-presenting cells (monocytes/dendritic cells), and more precisely on their activation by inflammatory stimuli. This study will allow us to determine our ability to recruit menopausal women and to characterize the optimal primary end-point among the numerous criteria tested
Condition | Intervention | Phase |
---|---|---|
Postmenopausal |
Drug: oestradiol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Effect of 17ß-Estradiol on Inflammatory-Immune Responses in Post-Menopausal Women According to Administration Route: Pilot Study |
Estimated Enrollment: | 34 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
oestradiol by oral administration
|
Drug: oestradiol
oestradiol 2 mg oral route 30 days
|
2: Experimental
oestradiol par patch
|
Drug: oestradiol
oestradio transdermal patch 60ug by 24 hours 30 days
|
Although the beneficial effects of hormonal replacement therapy (HRT) against osteoporosis and climacteric symptoms have been clearly established, randomized studies recently revealed that the combined administration of oral estrogens and medroxyprogesterone acetate increases the incidence of coronary events and strokes during the first months of treatment. Furthermore, oral estrogens significantly enhance IL-6 and CRP secretion. This increase in the plasma concentration of inflammatory markers probably results from a direct effect of oral administration on the liver, since i twas not observed with estrogens administered by transdermal route.
Our experimental data in ovariectomized mice demonstrated that the chronic subcutaneous administration of17ß-estradiol (E2) enhances the expression of pro-inflammatory cytokines by Th1 lymphocytes, Natural Killer T cells and monocytes/macrophages. This pro-inflammatory effect of E2 could play a role in the deleterious vascular effects observed in randomized studies, especially by favoring plaque instability.
Our aim is to determine whether E2 administration in menopausal women leads to an inflammatory phenotype of circulating antigen-presenting cells, especially monocytes. Indeed, evaluating the inflammatory status at the cellular level probably gives more precise informations than plasma cytokine concentrations to predict the ability of estrogens to enhance inflammatory processes. We first propose a pilot study in order to determine enrollment feasibility, as well as the optimal biological endpoints to assess monocyte activation status. These latter criteria will be then used in a future randomized study comparing two routes of E2 administration (oral vs transdermal).
The present study will include 34 menopausal women. After the inclusion visit, three visits will be performed with the collection of a 50 ml blood sample and the isolation of circulating immune cells (monocytes).
The following criteria will be studied before (V1 and V2) and after 30 ± 3 days of E2 treatment (V3:
We will first assess the intra-individual variability (V1 and V2). At visit 2 (V2), the subjects will be randomized to receive E2 either by oral (n= 17) or transdermal (n= 17) route.
Ages Eligible for Study: | 45 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Pierre GOURDY, MD | 33-56-132-2685 | gourdy.p@chu-toulouse.fr |
France | |
University Hospital Toulouse | Recruiting |
Toulouse, France, 31059 | |
Contact: Claude RIBOT, MD | |
Sub-Investigator: Florence TREMOLLIERES, MD | |
Sub-Investigator: Claude RIBOT, MD |
Principal Investigator: | Pierre GOURDY | Hospital University Toulouse |
Responsible Party: | University Hospital Toulouse ( LLAU Marie-Elise ) |
Study ID Numbers: | 0507402 |
Study First Received: | February 22, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00701337 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Estrogen Replacement Therapy menopausal women |
Estrogens Benzoates Contraceptive Agents Hormone Antagonists Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female |
Estradiol 17 beta-cypionate Hormones Estradiol Estradiol 3-benzoate Polyestradiol phosphate Menopause |
Estrogens Contraceptive Agents Estradiol valerate Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Estradiol 17 beta-cypionate |
Reproductive Control Agents Hormones Estradiol Pharmacologic Actions Estradiol 3-benzoate Therapeutic Uses Polyestradiol phosphate |