Status:
UNKNOWN
Effects of Estradiol on Menopausal Breast
Lead Sponsor:
Karolinska Institutet
Conditions:
Hormone Replacement Therapy
Eligibility:
FEMALE
50-60 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00785317
Start Date
November 1 2008
End Date
April 1 2010
Last Update
November 5 2008
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden