BrAVA: Effects of Estradiol on Menopausal Breast

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00785317
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hormone Replacement Therapy	Drug: Angemin vs Activelle	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2008
• Anticipated Primary Completion Date: Oct 1, 2009
• Anticipated Study Completion Date: Apr 1, 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Mammographic breast density - classified according to digitized data-based quantification of breast density. [6 months]

Secondary Outcome Measures

1. Effects on serum levels of Oestradiol etc. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden

Sponsors and Collaborators

• Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00785317
• Other Study ID Numbers: 080818
• First Posted: Nov 5, 2008
• Last Update Posted: Nov 5, 2008
• Last Verified: Nov 1, 2008

• Keywords provided by , ,: Postmenopausal Hormone Replacement Therapy

Study Results

No Results Posted as of Nov 5, 2008