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

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ClinicalTrials.gov Identifier: NCT00236301
Recruitment Status : Terminated (terminated)
First Posted : October 12, 2005
Last Update Posted : January 17, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : June 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Menopause
U.S. FDA Resources

Arms and Interventions

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
CLIMASTON
Drug: CLIMASTON (drug)
CLIMASTON(drug)
Placebo Comparator: 3
placebo
Drug: placebo
placebo


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00236301


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

Publications:

Responsible Party: Yannick Vacher, Department Clinical Research of Developement
ClinicalTrials.gov 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:
Hormone
Menopause
Inflammation
Dose effects
Apoptosis

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