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

S

Solvay Pharmaceuticals

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)

135 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: 17ß-Estradiol/Dydrogesterone
2
Active Comparator group
Treatment:
Drug: Tibolone

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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