Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-03-31

Brief Summary

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This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.

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Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

17ß-Estradiol/Dydrogesterone

Intervention Type DRUG

1/5 mg/day for 12 cycles of 28 days

2

Group Type ACTIVE_COMPARATOR

Tibolone

Intervention Type DRUG

2,5 mg/day for 12 cycles of 28 days

Interventions

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17ß-Estradiol/Dydrogesterone

1/5 mg/day for 12 cycles of 28 days

Intervention Type DRUG

Tibolone

2,5 mg/day for 12 cycles of 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
* non hysterectomized women, complaining of at least 14 hot flushes per week

Exclusion Criteria

* Known, suspected or history of breast cancer or hormone-dependent neoplasia,
* undiagnosed genital bleeding,
* venous or arterial history or presence of thromboembolism,
* cerebrovascular disease

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No