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

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00145522

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 IV

MedlinePlus related topics: Hormone Replacement Therapy Menopause

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Tibolone Dydrogesterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

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:	136
Study Start Date:	November 2005
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: 17ß-Estradiol/Dydrogesterone 1/5 mg/day for 12 cycles of 28 days
2: Active Comparator	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145522

Locations

Italy
Site 1
Torino, Italy
Site 2
Torino, Italy
Site 4
Catania, Italy
Site 6
Roma, Italy
Site 7
Udine, Italy
Site 15
Cagliari, Italy
Site 9
Firenze, Italy
Site 10
Milano, Italy
Site 11
Milano, Italy
Sit 14
Modena, Italy
Site 8
Ancona, Italy

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Irene Grazioli )
Study ID Numbers:	S102.4.103, 2004-001829-22
Study First Received:	September 2, 2005
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00145522
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Solvay Pharmaceuticals:

Menopause, IGF-1, HRT

Study placed in the following topic categories:

Dydrogesterone
Tibolone
Estradiol 3-benzoate
Estradiol valerate

Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol
Menopause

Additional relevant MeSH terms:

Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents
Antihypertensive Agents

Hormones
Pharmacologic Actions
Estrogen Receptor Modulators
Anabolic Agents
Androgen Antagonists
Progestins
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009