Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route
1 other identifier
interventional
40
1 country
1
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/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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 22, 2007
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedMay 11, 2017
May 1, 2017
3.3 years
February 22, 2007
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the feasibility of a future multicentric randomized trial : estimation of the number of subjects required
1 month
Secondary Outcomes (2)
variability and repeatability of the biological parameters studied
1 month
Feasibility of the recruitment, enrollment and follow-up of menopausal women
End of study
Study Arms (2)
1 Oral
EXPERIMENTALoestradiol by oral administration - Estrofem 2 mg
2 patch
EXPERIMENTALoestradiol par patch - Estrapatch 60microg/24h
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Ability to sign the consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Toulouse
Toulouse, 31059, France
Related Publications (1)
Seillet C, Laffont S, Tremollieres F, Rouquie N, Ribot C, Arnal JF, Douin-Echinard V, Gourdy P, Guery JC. The TLR-mediated response of plasmacytoid dendritic cells is positively regulated by estradiol in vivo through cell-intrinsic estrogen receptor alpha signaling. Blood. 2012 Jan 12;119(2):454-64. doi: 10.1182/blood-2011-08-371831. Epub 2011 Nov 16.
PMID: 22096248RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre GOURDY
Hospital University Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2007
First Posted
June 19, 2008
Study Start
September 1, 2006
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
May 11, 2017
Record last verified: 2017-05