Effects of Estradiol on Menopausal Breast
Information source: Karolinska Institutet
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hormone Replacement Therapy
Intervention: Angemin vs Activelle (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Karolinska Institutet Overall contact:
Eva Lundström, Phone: +46851770000, Email: eva.lunstrom@karolinska.se
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Parallel Assignment
Primary outcome: Mammographic breast density - classified according to digitized data-based quantification of breast density.
Secondary outcome: Effects on serum levels of Oestradiol etc.
Eligibility
Minimum age: 50 Years.
Maximum age: 60 Years.
Gender(s): Female.
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.
Locations and Contacts
Eva Lundström, Phone: +46851770000, Email: eva.lunstrom@karolinska.se
Karolinska University Hospital, Stockholm, Sweden; Recruiting
Eva Lundström, Principal Investigator
Additional Information
Starting date: November 2008
Ending date: April 2010
Last updated: November 4, 2008
|
