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OpenTrials
Completed

NCT Number: NCT00145522

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

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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Key information

Conditions

Menopause

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Site 8, Ancona, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

17ß-Estradiol/Dydrogesterone

Drug

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

Tibolone

Drug

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

Primary outcomes

  1. IGF1 values after 12 cycles of 28 days

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 5, 2005
Registry last updated
Apr 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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