NCT00785317UnknownPhase 4
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Karolinska Institutet
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Mammographic breast density - classified according to digitized data-based quantification of breast density.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •They should be free of any sex hormone treatment for at least three months before inclusion.
Exclusion Criteria
- •General contraindications for HT according to Swedish product label. Age >60 years. BMI ≤18 or ≥30 kg/m
- •Any previous history of cancer.
- •Any previous history of breast disease or abnormal mammogram.
- •In addition: hypertension (systolic BP >160 mm Hg or diastolic >100 mm Hg), hyperlipidemia (total cholesterol >8.0 mmol/L or triglycerides >3.0 mmol/L), diabetes mellitus, history of thromboembolic disease, heart failure, liver disease or porphyria, undiagnosed vaginal bleeding. No sex hormone treatment for at least three months before inclusion.
- •No concomitant treatment known to influence hormone metabolism (warfarin, rifampicin, carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum antibiotics) is to be accepted.
Arms & Interventions
Angemin
Experimental
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP
Intervention: Angemin vs Activelle (Drug)
Activelle
Active Comparator
1 mg of oral E2 in continuous combination with 0.5 mg of NETA
Intervention: Angemin vs Activelle (Drug)
Outcomes
Primary Outcomes
Mammographic breast density - classified according to digitized data-based quantification of breast density.
Time Frame: 6 months
Secondary Outcomes
- Effects on serum levels of Oestradiol etc.(6 months)
Investigators
Study Sites (1)
Loading locations...
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