Oral 1 mg oestradiol (E2) / 2 mg of drosperinone (DRSP) and 1 mg of oestradiol / 0.5 mg of norethisteroneacetate (NETA): effects on mammografic density and breast epithelial proliferation - an explorative prospective randomized open study

INTERVENTION: 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: 2,0‐ Other descriptive name: 17B‐ESTRADIOL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1,0‐ Trade Name: Activelle Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: NORETHISTERONE ACETATE CAS Number: 51989 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Other descriptive name: ESTRADIOL HEMIHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0‐ CONDITION: 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 PRIMARY OUTCOME: 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. 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.; Secondary Objective: 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