Healthy Symptomatic Menopausal Women Clinical Trial
— THSOfficial title:
Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women
Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.
| Status | Terminated |
| Enrollment | 99 |
| Est. completion date | January 2007 |
| Est. primary completion date | June 2006 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CIC, Saint Antoine Hospital | Paris cedex 12 |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | French Health Products Safety Agency, FRM, Solvay Pharmaceuticals |
France,
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hs-C-reactive protein | 2 months | No | |
| Secondary | Interleukin (IL-6, IL-18, IL-10), TNF-alpha, apoptotic microparticles, homocysteine, total cholesterol/HDL cholesterol, Lp(a), interleukin 6, ICAM soluble, | 2 months | No | |
| Secondary | Eslectin, prothrombin F1+2, factor VIII, resistance to activated protein C (RPCA or ACV test),IL 18, IL10, IL8 | 2 months | No |