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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00701337 |
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Date of registration:
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22/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route
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Scientific title:
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Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route: Pilot Study |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00701337 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Pierre GOURDY |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital University Toulouse |
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Key inclusion & exclusion criteria
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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.
Age minimum:
45 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postmenopausal
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Intervention(s)
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Drug: oestradiol
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Primary Outcome(s)
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To determine the feasibility of a future multicentric randomized trial : estimation of the number of subjects required
[Time Frame: 1 month]
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Secondary Outcome(s)
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variability and repeatability of the biological parameters studied
[Time Frame: 1 month]
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Feasibility of the recruitment, enrollment and follow-up of menopausal women
[Time Frame: End of study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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