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

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 3

Conditions: Healthy Symptomatic Menopausal Women

Treatments: Drug: CLIMASTON (drug); Drug: 17 Beta-estradiol (2mg/day)and (1mg/day); Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00236301

P021204

Details and patient eligibility

About

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

Full description

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

Enrollment: 99 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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99 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

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

2

Active Comparator group

Description:

CLIMASTON

Treatment:

Drug: CLIMASTON (drug)

3

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo