Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent...
Date First Received: October 11, 2005
Last Updated: January 16, 2008
Verified by: Assistance Publique - Hôpitaux de Paris, October 2005
Clinical Trial Phase: Phase 3 | Start Date: March 2004
Overall Status: Terminated
Estimated Enrollment: 99
Brief Summary
Official Title: “Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women”
Condition Keyword(s):
Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Study Primary Completion Date: June 2006
Detailed Clinical Trial Description
Pro-inflammatory study of the effects in short term of two difference doses of 17beta-estradiol at the menopause woman
Intervention(s) in this Clinical Trial
- Drug: CLIMASTON (drug)
- CLIMASTON(drug)
- Drug: 17 Beta-estradiol (2mg/day)and (1mg/day)
- 17 Beta-estradiol (2mg/day)and (1mg/day)
- Drug: placebo
- placebo
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- 17 Beta-estradiol (2mg/day)and (1mg/day)
- Active Comparator: 2
- CLIMASTON
- Placebo Comparator: 3
- placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Hs-C-reactive protein
- Time Frame: 2 months
Safety Issue?: No
- Time Frame: 2 months
Secondary 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
Safety Issue?: No
- Time Frame: 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
Safety Issue?: No
- Time Frame: 2 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Clinical Trial Officials and Contacts
Tabassome Simon, M.D., Ph.D. Principal Investigator Service de Pharmacologie (Pr Jaillon) CHU Saint-Antoine 27, rue de Chaligny, 75012 Paris
Related Publications
References
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[No authors listed] Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33.
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Teede HJ, McGrath BP, Smolich JJ, Malan E, Kotsopoulos D, Liang YL, Peverill RE. Postmenopausal hormone replacement therapy increases coagulation activity and fibrinolysis. Arterioscler Thromb Vasc Biol. 2000 May;20(5):1404-9.
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Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. 2000 Mar 23;342(12):836-43.
Mallat Z, Heymes C, Ohan J, Faggin E, Leseche G, Tedgui A. Expression of interleukin-10 in advanced human atherosclerotic plaques: relation to inducible nitric oxide synthase expression and cell death. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):611-6.
Mallat Z, Hugel B, Ohan J, Leseche G, Freyssinet JM, Tedgui A. Shed membrane microparticles with procoagulant potential in human atherosclerotic plaques: a role for apoptosis in plaque thrombogenicity. Circulation. 1999 Jan 26;99(3):348-53.
Mallat Z, Benamer H, Hugel B, Benessiano J, Steg PG, Freyssinet JM, Tedgui A. Elevated levels of shed membrane microparticles with procoagulant potential in the peripheral circulating blood of patients with acute coronary syndromes. Circulation. 2000 Feb 29;101(8):841-3.
Ridker PM, Hennekens CH, Rifai N, Buring JE, Manson JE. Hormone replacement therapy and increased plasma concentration of C-reactive protein. Circulation. 1999 Aug 17;100(7):713-6.
Cushman M, Legault C, Barrett-Connor E, Stefanick ML, Kessler C, Judd HL, Sakkinen PA, Tracy RP. Effect of postmenopausal hormones on inflammation-sensitive proteins: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Study. Circulation. 1999 Aug 17;100(7):717-22.
Scarabin PY, Alhenc-Gelas M, Oger E, Plu-Bureau G. Hormone replacement therapy and circulating ICAM-1 in postmenopausal women--a randomised controlled trial. Thromb Haemost. 1999 May;81(5):673-5.
van Baal WM, Smolders RG, van der Mooren MJ, Teerlink T, Kenemans P. Hormone replacement therapy and plasma homocysteine levels. Obstet Gynecol. 1999 Oct;94(4):485-91.
Additional Information
Information obtained from ClinicalTrials.gov on August 27, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00236301
Study ID Number: P021204
ClinicalTrials.gov Identifier: NCT00236301
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
