Dose Effects of Hormone Therapy (Two Doses of Estradiol Associated to Progesterone) on Inflammatory Markers

Study Overview
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Brief Summary
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Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.

Detailed Description
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Pro-inflammatory study of the effects in short term of two difference doses of 17beta-estradiol at the menopause woman

Official Title
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Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women

Conditions
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Healthy Symptomatic Menopausal Women

Intervention / Treatment
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* Drug: CLIMASTON (drug)
* Drug: 17 Beta-estradiol (2mg/day)and (1mg/day)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic menopausal women : >=50 years and amenorrhea >=1 year or <50 years and amenorrhea >=1 year and plasmatic FSH >= 30 UI/l Normal mammography in the last 2 years before inclusion Normal cervical smear in the last 2 years before inclusion Written consent for participation in the study Exclusion Criteria: Unconfirmed Menopause with amenorrhoea of less than year Oestrogen-progesterone Treatment anterior in 3 months previous the inclusion Recently a viral Infection or bacteriologic(at least of 2 weeks) Dental Infection Inflammatory Pathology chronicles Antecedent of pathology cancerous with or no a sly hemopathy Addiction to smoking of more than 20 cigarettes a day or an alcoholic consumption furthermore of 4 glasses a day Taken concomitant of one of the treatments forbidden:statine, vitamin B6 or B12, folates, antiinflammatory, anti aggregant Plaquettes, DHEA, phytoestrogens Refusal to sign the assent informed Not membership in a regime about social security

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>17 Beta-estradiol (2mg/day)and (1mg/day) | Drug: 17 Beta-estradiol (2mg/day)and (1mg/day)<br>* 17 Beta-estradiol (2mg/day)and (1mg/day)<br>|
| Active Comparator: 2<br>CLIMASTON | Drug: CLIMASTON (drug)<br>* CLIMASTON(drug)<br>|
| Placebo Comparator: 3<br>placebo | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hs-C-reactive protein |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin (IL-6, IL-18, IL-10), TNF-alpha, apoptotic microparticles, homocysteine, total cholesterol/HDL cholesterol, Lp(a), interleukin 6, ICAM soluble, |  | 2 months | 
| Eslectin, prothrombin F1+2, factor VIII, resistance to activated protein C (RPCA or ACV test),IL 18, IL10, IL8 |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone, Menopause, Inflammation, Dose effects, Apoptosis