BrAVAEffects of Oral E2/DRSP vs E2/NETA on Postmenopausal Breast
This study aims to compare the effects of Oral E2/DRSP and E2/NETA on breast density in postmenopausal women, as measured by digitized data-based quantification of mammographic breast density.
Angemin vs Activelle
Treatment Study
Summary
Study start date: November 1, 2008
Actual date on which the first participant was enrolled.This study focuses on postmenopausal women and aims to compare the effects of two different hormone therapies on the breast. The first therapy combines Oestradiol (E2) with Drospirenone (DRSP), while the second combines Oestradiol (E2) with Noresthisterone Acetate (NETA). The goal is to understand which therapy has a more favorable impact on the breast over a six-month period. This research is important as it could help improve the care and treatment options for postmenopausal women. During the study, participants are randomly assigned to one of the two hormone therapies. The first group receives an oral dose of 1 mg Oestradiol (E2) combined with 2 mg of Drospirenone (DRSP), while the second group receives an oral dose of 1 mg of Oestradiol (E2) combined with 0.5 mg Noresthisterone Acetate (NETA). The primary outcome measured is the mammographic breast density, which is evaluated using digitized data-based quantification of breast density. This helps to assess the changes in the breast tissue after the hormone therapies.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 50 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location