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

• Status: Terminated
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: French Health Products Safety Agency; FRM; Solvay Pharmaceuticals
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

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