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TerminatedNCT00236301THSUpdated Jan 17, 2008

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

A Phase 3 interventional study of CLIMASTON (drug) and 17 Beta-estradiol (2mg/day)and (1mg/day) in Healthy Symptomatic Menopausal Women, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-01-17.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment

Why this study was terminated
terminated
Phase
Phase 3
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.

Read the detailed description

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

02

Conditions studied

  • Healthy Symptomatic Menopausal Women

Keywords

  • Hormone
  • Menopause
  • Inflammation
  • Dose effects
  • Apoptosis
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
99 participants (actual)

Study arms

  • Active comparator
    1

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

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

  • Active comparator
    2

    CLIMASTON

    Drug: CLIMASTON (drug)

  • Placebo comparator
    3

    placebo

    Drug: placebo

Interventions

  • DrugCLIMASTON (drug)

    CLIMASTON(drug)

  • Drug17 Beta-estradiol (2mg/day)and (1mg/day)

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

  • Drugplacebo

    placebo

06

What researchers measure

Primary outcomes

  1. Hs-C-reactive protein

    Time frame: 2 months

Secondary outcomes

  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

07

Study locations

1 site
  • CIC, Saint Antoine Hospital
    Paris cedex 12, 75571, France
08

References and documents

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. doi: 10.1056/NEJM198704303161801. PubMed 3574358 ↗
  • 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. PubMed 11730394 ↗
  • 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. PubMed 12117397 ↗
  • 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. PubMed 10362825 ↗
  • 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. PubMed 9409295 ↗
  • 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. PubMed 10807761 ↗
  • 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. PubMed 7589641 ↗
  • 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. PubMed 10733371 ↗
  • 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. PubMed 10073964 ↗
  • 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. PubMed 9918520 ↗
  • 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. PubMed 10694520 ↗
  • 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. PubMed 10449692 ↗
  • 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. PubMed 10449693 ↗
  • 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. PubMed 10365734 ↗
  • 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. PubMed 10511346 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00236301
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
French Health Products Safety Agency, FRM, Solvay Pharmaceuticals
First posted
Oct 12, 2005
Start date
Mar 2004
Primary completion
Jun 2006
Completion
Jan 2007
Last update
Jan 17, 2008

Study contacts

Tabassome Simon, M.D., Ph.D.
principal investigator · Service de Pharmacologie (Pr Jaillon) CHU Saint-Antoine 27, rue de Chaligny, 75012 Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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