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

A Twelve 28-Day Cycles, Multicenter, Prospective, Randomized, Open, Blinded Endpoint, Parallel Group Study Comparing the Effect on Breast and Cardiovascular Metabolic Markers of Continuously Combined 17β-Estradiol/Dydrogesterone and Tibolone in Postmenopausal Women.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00145522

Enrollment

135

Registered

2005-09-05

Start date

2005-11-30

Completion date

2009-03-31

Last updated

2009-04-01

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

Conditions

Menopause

Keywords

Menopause, IGF-1, HRT

Brief summary

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.

Interventions

DRUG17ß-Estradiol/Dydrogesterone

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

DRUGTibolone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
IGF1 values after 12 cycles of 28 days	1 year

Secondary

Measure	Time frame
after 12 cycles of 28 days: other breast metabolic markers [IGFBP 1 and 3, SHBG, free estradiol, fasting insulin], breast tenderness and breast density, cardiovascular metabolic markers, menopausal symptoms and bleeding pattern	1 year

Countries

Italy

Outcome results

None listed

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