Postmenopausal Clinical Trial
Official title:
Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route: Pilot Study
Verified date | May 2017 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 40 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Women with confirmed menopause (duration : 1 to 5 years) - No contra-indication of hormonal replacement therapy due to medical history - Mammogram without significant abnormality (< 12 months) - Normal body mass index (BMI) (19 = IMC = 25 kg/m2) - No treatment with estrogens and/or progestatives and/or SERM (specific moduator of estrogen receptor) and/or phytoestrogènes ongoing or stopped for less than 3 months - No clinical or biological abnormality or treatment indicating the presence of an infectious or inflammatory disease. - No participation to another clinical study during the 3 months before the inclusion - Ability to sign the consent form. |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Seillet C, Laffont S, Trémollières F, Rouquié N, Ribot C, Arnal JF, Douin-Echinard V, Gourdy P, Guéry JC. The TLR-mediated response of plasmacytoid dendritic cells is positively regulated by estradiol in vivo through cell-intrinsic estrogen receptor a sig — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the feasibility of a future multicentric randomized trial : estimation of the number of subjects required | 1 month | ||
Secondary | variability and repeatability of the biological parameters studied | number of circulating immune cells, expression of surface molecules by monocytes, secretion of cytokines following TLR activation | 1 month | |
Secondary | Feasibility of the recruitment, enrollment and follow-up of menopausal women | End of study |
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