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Sponsored by: |
Karolinska Institutet |
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Information provided by: | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00785317 |
The purpose of this study is to evaluate the effects on breast in postmenopausal women randomized to either oestradiol in combination with DRSP or E2 in combination with NETA during six months.
Condition | Intervention | Phase |
---|---|---|
Hormone Replacement Therapy |
Drug: Angemin vs Activelle |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Effects of Oral 1 mg Oestradiol (E2)/ 2 mg of Drospirenone (DRSP) Compared to Oral 1 mg of Oestradiol (E2)/ 0.5 mg Noresthisterone Acetate (NETA)on the Postmenopausal Breast; a Double Blind Randomized Prospective Study |
Estimated Enrollment: | 120 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Angemin: Experimental
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP
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Drug: Angemin vs Activelle
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP or 1 mg of oral E2 in continuous combination with 0.5 mg of NETA during six months.
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Activelle: Active Comparator
1 mg of oral E2 in continuous combination with 0.5 mg of NETA
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Drug: Angemin vs Activelle
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP or 1 mg of oral E2 in continuous combination with 0.5 mg of NETA during six months.
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Ages Eligible for Study: | 50 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eva Lundström | +46851770000 | eva.lunstrom@karolinska.se |
Sweden | |
Karolinska University Hospital | Recruiting |
Stockholm, Sweden | |
Principal Investigator: Eva Lundström |
Responsible Party: | Karolinska University Hospital ( Eva Lundström, MD, PhD ) |
Study ID Numbers: | 080818 |
Study First Received: | November 4, 2008 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00785317 History of Changes |
Health Authority: | Sweden: The National Board of Health and Welfare |
Postmenopausal Hormone Replacement Therapy |
Estrogens Hormone Antagonists Estradiol 3-benzoate Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Drospirenone |
Estradiol 17 beta-cypionate Polyestradiol phosphate Hormones Estradiol Menopause |
Estrogens Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Hormones Pharmacologic Actions Estradiol |