Trial | NCT00236301  Report issue

Title

Dose Effects of Hormone Therapy (Two Doses of Estradiol Associated to Progesterone) on Inflammatory Markers
Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    estradiol ...

  • Study Participants

    99
Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.
Pro-inflammatory study of the effects in short term of two difference doses of 17beta-estradiol at the menopause woman
Study Started
Mar 31
2004
Primary Completion
Jun 30
2006
Study Completion
Jan 31
2007
Last Update
Jan 17
2008
Estimate

Drug CLIMASTON (drug)

CLIMASTON(drug)

Drug 17 Beta-estradiol (2mg/day)and (1mg/day)

17 Beta-estradiol (2mg/day)and (1mg/day)

Drug placebo

placebo

1 Active Comparator

17 Beta-estradiol (2mg/day)and (1mg/day)

2 Active Comparator

CLIMASTON

3 Placebo Comparator

placebo

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
No Results Posted