Effects of Estradiol on Menopausal Breast

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-04-30

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.

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Detailed Description

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Conditions

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Hormone Replacement Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Angemin

1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP

Group Type EXPERIMENTAL

Angemin vs Activelle

Intervention Type DRUG

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.

Activelle

1 mg of oral E2 in continuous combination with 0.5 mg of NETA

Group Type ACTIVE_COMPARATOR

Angemin vs Activelle

Intervention Type DRUG

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.

Interventions

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Angemin vs Activelle

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.

Intervention Type DRUG

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes