The effect of hormonal treatment on mammographic density and breast epithelial proliferation in postmenopausal women. MedDRA version: 9.1 Level: LLT Classification code 10020422 Term: HRT
Conditions
Interventions
Trade Name: Angemin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DROSPIRENONE
CAS Number: 67392874
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. 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 (wafarin, rifampicin, carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum antibiotics) is to be accepted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to evaluate the effects on mammographic breast density and breast cell proliferation and apoptosis in postmenopausal women randomized to either 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. Breast symptom questionnaire. ;Secondary Objective: ;Primary end point(s): Mammographic breast density - classified according to digitized data-based quantification of breast density. Breast epithelial proliferation by the percentage of proliferating cells that will be stained positive by the Ki-67/MIB-1 monoclonal antibody. | — |
Countries
Sweden
Outcome results
None listed