Effects of Estradiol on Menopausal Breast (BrAVA)

Karolinska Institute

Status and phase: Unknown; Phase 4

Conditions: Hormone Replacement Therapy

Treatments: Drug: Angemin vs Activelle

Study type: Interventional

Funder types: Other

Identifiers

NCT00785317

080818

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 50 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Angemin

Experimental group

Description:

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

Treatment:

Drug: Angemin vs Activelle

Activelle

Active Comparator group

Description:

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

Treatment:

Drug: Angemin vs Activelle