Status:
TERMINATED
Dose Effects of Hormone Therapy (Two Doses of Estradiol Associated to Progesterone) on Inflammatory Markers
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
French Health Products Safety Agency
FRM
Conditions:
Healthy Symptomatic Menopausal Women
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00236301
Start Date
March 1 2004
End Date
January 1 2007
Last Update
January 17 2008
Active Locations (1)
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1
CIC, Saint Antoine Hospital
Paris, France, 75571