Clinical trial NCT00236301: Dose Effects of Hormone Therapy (Two Doses of Estradiol Associated to Progesterone) on Inflammatory Markers
Official title: Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Healthy Symptomatic Menopausal Women
Keywords: Hormone
Menopause
Inflammation
Dose effects
Apoptosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: French Health Products Safety Agency
name: FRM
name: Solvay Pharmaceuticals
First posted: 2005-10-12
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Pro-inflammatory study of the effects in short term of two difference doses of 17beta-estradiol at the menopause woman

Eligibility criteria: 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

Primary outcomes:
measure: Hs-C-reactive protein
timeFrame: 2 months
Secondary outcomes:
measure: Interleukin (IL-6, IL-18, IL-10), TNF-alpha, apoptotic microparticles, homocysteine, total cholesterol/HDL cholesterol, Lp(a), interleukin 6, ICAM soluble,
timeFrame: 2 months
measure: Eslectin, prothrombin F1+2, factor VIII, resistance to activated protein C (RPCA or ACV test),IL 18, IL10, IL8
timeFrame: 2 months
Other outcomes:
Locations:
city: Paris cedex 12
country: France
facility: CIC, Saint Antoine Hospital
Study officials:
affiliation: Service de Pharmacologie (Pr Jaillon) CHU Saint-Antoine 27, rue de Chaligny, 75012 Paris
name: Tabassome Simon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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