Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Female

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/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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

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.