Effects of Estradiol on Menopausal Breast
BrAVA
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
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 4, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedNovember 5, 2008
November 1, 2008
11 months
November 4, 2008
November 4, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mammographic breast density - classified according to digitized data-based quantification of breast density.
6 months
Secondary Outcomes (1)
Effects on serum levels of Oestradiol etc.
6 months
Study Arms (2)
Angemin
EXPERIMENTAL1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP
Activelle
ACTIVE COMPARATOR1 mg of oral E2 in continuous combination with 0.5 mg of NETA
Interventions
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.
Eligibility Criteria
You may qualify if:
- Naturally postmenopausal, symptomatic, apparently healthy women, with the need for hormone therapy aged 50 - 70 years with a BMI \>18 and ≤30 kg/m2 and without any previous history of breast disease will be recruited for the study.
- They should be amenorrheic for at least 12 months or less than 12 months with S- FSH values \>40 IU/L.
You may not qualify if:
- General contraindications for HT according to Swedish product label. Age \>60 years. BMI ≤18 or ≥30 kg/m2.
- Any previous history of cancer.
- Any previous history of breast disease or abnormal mammogram.
- No concomitant treatment known to influence hormone metabolism (warfarin, rifampicin, carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum antibiotics) is to be accepted.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital
Stockholm, Sweden
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 4, 2008
First Posted
November 5, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2009
Study Completion
April 1, 2010
Last Updated
November 5, 2008
Record last verified: 2008-11