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Dose Effects of Hormone Therapy (Two Doses of Estradiol Associated to Progesterone) on Inflammatory Markers (THS)
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First Received on October 11, 2005.   Last Updated on January 16, 2008   History of Changes
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: French Health Products Safety Agency
FRM
Solvay Pharmaceuticals
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00236301
  Purpose

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 III

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:

MedlinePlus related topics: Menopause
Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate
U.S. FDA Resources

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)
Other Name: 17 Beta-estradiol (2mg/day)and (1mg/day)
Active Comparator: 2
CLIMASTON
 Drug: CLIMASTON (drug)
CLIMASTON(drug)
Other Name: CLIMASTON (drug)
Placebo Comparator: 3
placebo
 Drug: placebo
placebo
Other Name: placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Colditz GA, Willett WC, Stampfer MJ, Rosner B, Speizer FE, Hennekens CH. Menopause and the risk of coronary heart disease in women. N Engl J Med. 1987 Apr 30;316(18):1105-10.
Hodis HN, Mack WJ, Lobo RA, Shoupe D, Sevanian A, Mahrer PR, Selzer RH, Liu Cr CR, Liu Ch CH, Azen SP; Estrogen in the Prevention of Atherosclerosis Trial Research Group. Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Dec 4;135(11):939-53.
[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.
Mendelsohn ME, Karas RH. The protective effects of estrogen on the cardiovascular system. N Engl J Med. 1999 Jun 10;340(23):1801-11. Review. No abstract available.
Scarabin PY, Alhenc-Gelas M, Plu-Bureau G, Taisne P, Agher R, Aiach M. Effects of oral and transdermal estrogen/progesterone regimens on blood coagulation and fibrinolysis in postmenopausal women. A randomized controlled trial. Arterioscler Thromb Vasc Biol. 1997 Nov;17(11):3071-8.
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.
Conard J, Basdevant A, Thomas JL, Ochsenbein E, Denis C, Guyene TT, Degrelle H. Cardiovascular risk factors and combined estrogen-progestin replacement therapy: a placebo-controlled study with nomegestrol acetate and estradiol. Fertil Steril. 1995 Nov;64(5):957-62.
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.

Responsible Party: Yannick Vacher, Department Clinical Research of Developement
ClinicalTrials.gov 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 - French Health Products Safety Agency

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hormone
Menopause
Inflammation
Dose effects
Apoptosis

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

ClinicalTrials.gov processed this record on February 09, 2012



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