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.