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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00145522
First received: September 2, 2005
Last updated: March 31, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00145522

Locations
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, Italy
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Irene Grazioli, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00145522     History of Changes
Other Study ID Numbers: S102.4.103, 2004-001829-22
Study First Received: September 2, 2005
Last Updated: March 31, 2009
Health Authority: Italy: The Italian Medicines Agency

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

Additional relevant MeSH terms:
Estradiol
Tibolone
Dydrogesterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents
Progestins

ClinicalTrials.gov processed this record on September 29, 2014