Effects of Estradiol on Menopausal Breast

Phase 4

• Conditions: Hormone Replacement Therapy
• Interventions: Drug: Angemin vs Activelle

• Registration Number: NCT00785317
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Last Update Submitted: 2008-11-04
• Study First Posted: 2008-11-05
• Last Update Posted: 2008-11-05
• Primary Completion: 2009-10
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angemin	Angemin vs Activelle	1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP
Activelle	Angemin vs Activelle	1 mg of oral E2 in continuous combination with 0.5 mg of NETA

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effects on serum levels of Oestradiol etc.	6 months

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden