Effects of Estradiol on Menopausal Breast

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Oral 1 mg Oestradiol (E2)/ 2 mg of Drospirenone (DRSP) Compared to Oral 1 mg of Oestradiol (E2)/ 0.5 mg Noresthisterone Acetate (NETA)on the Postmenopausal Breast; a Double Blind Randomized Prospective Study

Conditions
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Hormone Replacement Therapy

Intervention / Treatment
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* Drug: Angemin vs Activelle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angemin<br>1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP | Drug: Angemin vs Activelle<br>* 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.<br>|
| Active Comparator: Activelle<br>1 mg of oral E2 in continuous combination with 0.5 mg of NETA | Drug: Angemin vs Activelle<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mammographic breast density - classified according to digitized data-based quantification of breast density. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on serum levels of Oestradiol etc. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal Hormone Replacement Therapy