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

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: September 2, 2005
Last updated: March 31, 2009
Last verified: March 2009
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 Intervention Phase
Menopause Drug: 17ß-Estradiol/Dydrogesterone Drug: Tibolone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 135
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   45 Years to 65 Years   (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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00145522

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
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Irene Grazioli, Solvay Pharmaceuticals Identifier: NCT00145522     History of Changes
Other Study ID Numbers: S102.4.103
Study First Received: September 2, 2005
Last Updated: March 31, 2009

Keywords provided by Solvay Pharmaceuticals:
Menopause, IGF-1, HRT

Additional relevant MeSH terms:
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antihypertensive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female processed this record on June 23, 2017