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

Conditions: The effect of hormonal treatment on mammographic density and breast epithelial proliferation in postmenopausal women.
MedDRA version: 9.1Level: LLTClassification code 10020422Term: HRT

Registration Number: EUCTR2008-003654-15-SE

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 120

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

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.