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NCT00145522 Clinical Trial

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

Menopause Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00145522
Other study ID # S102.4.103
Secondary ID 2004-001829-22
Status Completed
Phase Phase 4
First received September 2, 2005
Last updated March 31, 2009
Start date November 2005
Est. completion date March 2009

Study information
Verified date March 2009
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 135
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 17ß-Estradiol/Dydrogesterone
1/5 mg/day for 12 cycles of 28 days
• Tibolone
2,5 mg/day for 12 cycles of 28 days

Locations
Country Name City State
Italy Site 8 Ancona
Italy Site 15 Cagliari
Italy Site 4 Catania
Italy Site 9 Firenze
Italy Site 10 Milano
Italy Site 11 Milano
Italy Sit 14 Modena
Italy Site 6 Roma
Italy Site 1 Torino
Italy Site 2 Torino
Italy Site 7 Udine

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary IGF1 values after 12 cycles of 28 days 1 year No
Secondary 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 No
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