Effects of Estradiol on Menopausal Breast

Hormone Replacement Therapy Clinical Trial

— BrAVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00785317
• Other study ID #: 080818
• Status: Recruiting
• Phase: Phase 4
• First received: November 4, 2008
• Last updated: November 4, 2008
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: November 2008
• Source: Karolinska Institutet
• Contact: Eva Lundström
• Phone: +46851770000
• Email: eva.lunstrom[@]karolinska.se
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hormone Replacement Therapy

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mammographic breast density - classified according to digitized data-based quantification of breast density.		6 months	Yes
Secondary	Effects on serum levels of Oestradiol etc.		6 months	Yes