NCT00236301

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 17, 2008

Status Verified

October 1, 2005

Enrollment Period

2.3 years

First QC Date

October 11, 2005

Last Update Submit

January 16, 2008

Conditions

Healthy Symptomatic Menopausal Women

Keywords

HormoneMenopauseInflammationDose effectsApoptosis

Outcome Measures

Primary Outcomes (1)

  • Hs-C-reactive protein

    2 months

Secondary Outcomes (2)

  • Interleukin (IL-6, IL-18, IL-10), TNF-alpha, apoptotic microparticles, homocysteine, total cholesterol/HDL cholesterol, Lp(a), interleukin 6, ICAM soluble,

    2 months

  • Eslectin, prothrombin F1+2, factor VIII, resistance to activated protein C (RPCA or ACV test),IL 18, IL10, IL8

    2 months

Study Arms (3)

1

ACTIVE COMPARATOR

17 Beta-estradiol (2mg/day)and (1mg/day)

Drug: 17 Beta-estradiol (2mg/day)and (1mg/day)

2

ACTIVE COMPARATOR

CLIMASTON

Drug: CLIMASTON (drug)

3

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

CLIMASTON (drug)DRUG

CLIMASTON(drug)

2
17 Beta-estradiol (2mg/day)and (1mg/day)DRUG

17 Beta-estradiol (2mg/day)and (1mg/day)

1
placeboDRUG

placebo

3

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic menopausal women : \>=50 years and amenorrhea \>=1 year or \<50 years and amenorrhea \>=1 year and plasmatic FSH \>= 30 UI/l
  • Written consent for participation in the study

You may not qualify if:

  • Unconfirmed Menopause with amenorrhoea of less than year
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC, Saint Antoine Hospital

Paris, 75571, France

Location

Related Publications (15)

  • 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. doi: 10.1056/NEJM198704303161801.

    PMID: 3574358BACKGROUND

  • 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. doi: 10.7326/0003-4819-135-11-200112040-00005.

    PMID: 11730394BACKGROUND

  • Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. 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. doi: 10.1001/jama.288.3.321.

    PMID: 12117397BACKGROUND

  • Mendelsohn ME, Karas RH. The protective effects of estrogen on the cardiovascular system. N Engl J Med. 1999 Jun 10;340(23):1801-11. doi: 10.1056/NEJM199906103402306. No abstract available.

    PMID: 10362825BACKGROUND

  • 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. doi: 10.1161/01.atv.17.11.3071.

    PMID: 9409295BACKGROUND

  • 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. doi: 10.1161/01.atv.20.5.1404.

    PMID: 10807761BACKGROUND

  • 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. doi: 10.1016/s0015-0282(16)57909-6.

    PMID: 7589641BACKGROUND

  • 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. doi: 10.1056/NEJM200003233421202.

    PMID: 10733371BACKGROUND

  • 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. doi: 10.1161/01.atv.19.3.611.

    PMID: 10073964BACKGROUND

  • 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. doi: 10.1161/01.cir.99.3.348.

    PMID: 9918520BACKGROUND

  • 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. doi: 10.1161/01.cir.101.8.841.

    PMID: 10694520BACKGROUND

  • 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. doi: 10.1161/01.cir.100.7.713.

    PMID: 10449692BACKGROUND

  • 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. doi: 10.1161/01.cir.100.7.717.

    PMID: 10449693BACKGROUND

  • 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.

    PMID: 10365734BACKGROUND

  • 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. doi: 10.1016/s0029-7844(99)00412-3.

    PMID: 10511346BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Pharmaceutical PreparationsEstradiol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Tabassome Simon, M.D., Ph.D.

    Service de Pharmacologie (Pr Jaillon) CHU Saint-Antoine 27, rue de Chaligny, 75012 Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 12, 2005

Study Start

March 1, 2004

Primary Completion

June 1, 2006

Study Completion

January 1, 2007

Last Updated

January 17, 2008

Record last verified: 2005-10

Locations

FR(1)