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

January 16, 2008 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Pro-inflammatory study of the effects in short term of two difference doses of 17beta-estradiol at the menopause woman

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris cedex 12, France, 75571
        • CIC, Saint Antoine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
placebo
Drug: placebo
placebo
Active Comparator: 1
17 Beta-estradiol (2mg/day)and (1mg/day)
Drug: 17 Beta-estradiol (2mg/day)and (1mg/day)
17 Beta-estradiol (2mg/day)and (1mg/day)
Active Comparator: 2
CLIMASTON
Drug: CLIMASTON (drug)
CLIMASTON(drug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hs-C-reactive protein
Time Frame: 2 months
2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Solvay Pharmaceuticals
French Health Products Safety Agency
FRM

Investigators

  • Principal Investigator: Tabassome Simon, M.D., Ph.D., Service de Pharmacologie (Pr Jaillon) CHU Saint-Antoine 27, rue de Chaligny, 75012 Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

October 11, 2005

First Submitted That Met QC Criteria

October 11, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 17, 2008

Last Update Submitted That Met QC Criteria

January 16, 2008

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P021204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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