Effects of Estradiol on Menopausal Breast (BrAVA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hormone Replacement Therapy
• Intervention / Treatment: Drug: Angemin vs Activelle

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eva Lundström; Phone Number: +46851770000; Email: eva.lunstrom@karolinska.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Principal Investigator: Eva Lundström

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Angemin; 1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP	Drug: 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.
Active Comparator: Activelle; 1 mg of oral E2 in continuous combination with 0.5 mg of NETA	Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): October 1, 2009
• Study Completion (Anticipated): April 1, 2010

Study Registration Dates

• First Submitted: November 4, 2008
• First Submitted That Met QC Criteria: November 4, 2008
• First Posted (Estimate): November 5, 2008

Study Record Updates

• Last Update Posted (Estimate): November 5, 2008
• Last Update Submitted That Met QC Criteria: November 4, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Postmenopausal Hormone Replacement Therapy
• Other Study ID Numbers: 080818