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

This study has been terminated.
French Health Products Safety Agency
Solvay Pharmaceuticals
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: October 11, 2005
Last updated: January 16, 2008
Last verified: October 2005
Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Hs-C-reactive protein [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: March 2004
Study Completion Date: January 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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Please refer to this study by its identifier: 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
  More Information


Responsible Party: Yannick Vacher, Department Clinical Research of Developement Identifier: NCT00236301     History of Changes
Other Study ID Numbers: P021204 
Study First Received: October 11, 2005
Last Updated: January 16, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on February 04, 2016