Effects of Estradiol on Menopausal Breast

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00785317

Acronym

BrAVA

Enrollment

120

Registered

2008-11-05

Start date

2008-11-30

Completion date

2010-04-30

Last updated

2008-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone Replacement Therapy

Keywords

Postmenopausal Hormone Replacement Therapy

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.

Interventions

DRUGAngemin 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Mammographic breast density - classified according to digitized data-based quantification of breast density.	6 months

Secondary

Measure	Time frame
Effects on serum levels of Oestradiol etc.	6 months

Countries

Sweden

Contacts

Primary ContactEva Lundström

eva.lunstrom@karolinska.se+46851770000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026