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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145522
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : April 1, 2009
Information provided by:
Solvay Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Menopause Drug: 17ß-Estradiol/Dydrogesterone Drug: Tibolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : November 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Estradiol

Arm Intervention/treatment
Experimental: 1 Drug: 17ß-Estradiol/Dydrogesterone
1/5 mg/day for 12 cycles of 28 days

Active Comparator: 2 Drug: Tibolone
2,5 mg/day for 12 cycles of 28 days

Primary Outcome Measures :
  1. IGF1 values after 12 cycles of 28 days [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145522

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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, Italy
Sponsors and Collaborators
Solvay Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
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Responsible Party: Irene Grazioli, Solvay Pharmaceuticals Identifier: NCT00145522    
Other Study ID Numbers: S102.4.103
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: March 2009
Keywords provided by Solvay Pharmaceuticals:
Menopause, IGF-1, HRT
Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antihypertensive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents