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Study to Compare the Effect of HRT on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women. - Article


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Ethinyl Estradiol and Ethynodiol Diacetate

Demulen 1/35; Demulen 1/50; Zovia 1/35 E; Zovia 1/50 E 



Clinical Trial: Study to Compare the Effect of HRT on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women.

This study is not yet open for patient recruitment.
Verified by Solvay Pharmaceuticals July 2005

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: 17b-estradiol (1 mg)/dydrogesterone (5 mg)
 Phase IV

MedlinePlus consumer health information 

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.

Eligibility

Ages Eligible for Study:  45 Years   -   65 Years,  Genders Eligible for Study:  Female
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 hystory of breast cancer or hormone-dependent neoplasia, undiagnosed genital bleeding, venous or arterial hystory or presence of thromboembolism, cerebrovascular disease

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00145522

Irene Grazioli       Irene.grazioli@solvay.com

Italy
      Site 1, Torino,  Italy
see Central Contact

      Site 2, Torino,  Italy
see Central Contact

      Site 3, Pavia,  Italy
see Central Contact

      Site 4, Catania,  Italy
see Central Contact

      Site 5, Roma,  Italy
see Central Contact

      Site 6, Roma,  Italy
see Central Contact

      Site 7, Udine,  Italy
see Central Contact

Study chairs or principal investigators

Global Clinical Director Solvay,  Study Director,  Solvay Pharmaceuticals   

More Information

Study ID Numbers:  S102.4.103
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00145522
Health Authority: Italy: The Italian Medicines Agency
ClinicalTrials.gov processed this record on 2005-09-06


Source: ClinicalTrials.gov
Cache Date: September 7, 2005

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Page Updated: June 1, 2005
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