Not Signed In -
Estradiol Injection |
Delestrogen; Depo-Estradiol; Estra-L; Gynogen; Valergen |
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
|
Purpose
| 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
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
Italy
Site 1, Torino, Italy
Site 2, Torino, Italy
Site 3, Pavia, Italy
Site 4, Catania, Italy
Site 5, Roma, Italy
Site 6, Roma, Italy
Site 7, Udine, Italy
Global Clinical Director Solvay, Study Director, Solvay Pharmaceuticals
More Information
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
Resources
- Delestrogen (Drug Digest)
- Depo-Estradiol (Drug Digest)
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