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

Phase 3

Terminated

• Conditions: Healthy Symptomatic Menopausal Women
• Interventions: Drug: placebo; Drug: CLIMASTON (drug); Drug: 17 Beta-estradiol (2mg/day)and (1mg/day)

• Registration Number: NCT00236301
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2004-03
• Status Verified: 2005-10
• Study First Submitted: 2005-10-11
• Study First Submitted QC: 2005-10-11
• Study First Posted: 2005-10-12
• Primary Completion: 2006-06
• Study Completion: 2007-01
• Last Update Submitted: 2008-01-16
• Last Update Posted: 2008-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 99

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	placebo	placebo
2	CLIMASTON (drug)	CLIMASTON
1	17 Beta-estradiol (2mg/day)and (1mg/day)	17 Beta-estradiol (2mg/day)and (1mg/day)

Primary Outcome Measures

Name	Time	Method
Hs-C-reactive protein	2 months

Secondary Outcome Measures

Name	Time	Method
Interleukin (IL-6, IL-18, IL-10), TNF-alpha, apoptotic microparticles, homocysteine, total cholesterol/HDL cholesterol, Lp(a), interleukin 6, ICAM soluble,	2 months
Eslectin, prothrombin F1+2, factor VIII, resistance to activated protein C (RPCA or ACV test),IL 18, IL10, IL8	2 months

Trial Locations

Locations (1)

CIC, Saint Antoine Hospital; 🇫🇷 Paris cedex 12, France