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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236301
Recruitment Status : Terminated (terminated)
First Posted : October 12, 2005
Last Update Posted : January 17, 2008
French Health Products Safety Agency
Solvay Pharmaceuticals
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Symptomatic Menopausal Women Drug: CLIMASTON (drug) Drug: 17 Beta-estradiol (2mg/day)and (1mg/day) Drug: placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women
Study Start Date : March 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Menopause

Arm Intervention/treatment
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
Drug: CLIMASTON (drug)

Placebo Comparator: 3
Drug: placebo

Primary Outcome Measures :
  1. Hs-C-reactive protein [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. 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. Eslectin, prothrombin F1+2, factor VIII, resistance to activated protein C (RPCA or ACV test),IL 18, IL10, IL8 [ Time Frame: 2 months ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00236301

CIC, Saint Antoine Hospital
Paris cedex 12, France, 75571
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
French Health Products Safety Agency
Solvay Pharmaceuticals
Principal Investigator: Tabassome Simon, M.D., Ph.D. Service de Pharmacologie (Pr Jaillon) CHU Saint-Antoine 27, rue de Chaligny, 75012 Paris


Responsible Party: Yannick Vacher, Department Clinical Research of Developement Identifier: NCT00236301     History of Changes
Other Study ID Numbers: P021204
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: October 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Dose effects

Additional relevant MeSH terms:
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female