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

Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00236301

Acronym

THS

Enrollment

Registered

2005-10-12

Start date

2004-03-31

Completion date

2007-01-31

Last updated

2008-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Symptomatic Menopausal Women

Keywords

Hormone, Menopause, Inflammation, Dose effects, Apoptosis

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.

Detailed description

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

Interventions

DRUGCLIMASTON (drug)

CLIMASTON(drug)

DRUG17 Beta-estradiol (2mg/day)and (1mg/day)

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

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hs-C-reactive protein	2 months

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026