Status:
COMPLETED
Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Postmenopausal
Eligibility:
FEMALE
45-60 years
Phase:
PHASE4
Brief Summary
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/dendri...
Detailed Description
Although the beneficial effects of hormonal replacement therapy (HRT) against osteoporosis and climacteric symptoms have been clearly established, randomized studies recently revealed that the combine...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00701337
Start Date
September 1 2006
End Date
January 1 2010
Last Update
May 11 2017
Active Locations (1)
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1
University Hospital Toulouse
Toulouse, France, 31059