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Dose Effects of Hormone Therapy (Two Doses of Estradiol Associated to Progesterone) on Inflammatory Markers (THS)
This study has been terminated.
( terminated )
Study NCT00236301   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: October 11, 2005   Last Updated: January 16, 2008   History of Changes

October 11, 2005
January 16, 2008
March 2004
June 2006   (final data collection date for primary outcome measure)
Hs-C-reactive protein [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Hs-C-reactive protein
Complete list of historical versions of study NCT00236301 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Eslectin, prothrombin F1+2, factor VIII, resistance to activated protein C (RPCA or ACV test),IL 18, IL10, IL8 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Interleukin (IL-6, IL-18, IL-10), TNF-alpha, apoptotic microparticles, homocysteine, total cholesterol/HDL cholesterol, Lp(a), interleukin 6, ICAM soluble,
  • Eselectin, prothrombin F1+2, factor VIII, resistance to activated protein C (RPCA or ACV test),IL 18, IL10, IL8
 
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

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

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Healthy Symptomatic Menopausal Women
  • Drug: CLIMASTON (drug)
  • Drug: 17 Beta-estradiol (2mg/day)and (1mg/day)
  • Drug: placebo
  • Active Comparator: 17 Beta-estradiol (2mg/day)and (1mg/day)
  • Active Comparator: CLIMASTON
  • Placebo Comparator: placebo

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
99
January 2007
June 2006   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00236301
Yannick Vacher, Department Clinical Research of Developement
P021204
Assistance Publique - Hôpitaux de Paris
  • French Health Products Safety Agency
  • FRM
  • Solvay Pharmaceuticals
Principal Investigator: Tabassome Simon, M.D., Ph.D. Service de Pharmacologie (Pr Jaillon) CHU Saint-Antoine 27, rue de Chaligny, 75012 Paris
Assistance Publique - Hôpitaux de Paris
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP