Overview

Effects of Estradiol on Menopausal Breast

Status:
Unknown status
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Karolinska Institutet
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate
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.

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 (warfarin, rifampicin,
carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum
antibiotics) is to be accepted.