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

Solvay

Status and phase: Completed; Phase 4

Conditions: Menopause

Treatments: Drug: Tibolone; Drug: 17ß-Estradiol/Dydrogesterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00145522

2004-001829-22

S102.4.103

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: 17ß-Estradiol/Dydrogesterone

2

Active Comparator group

Treatment:

Drug: Tibolone