Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Estradiol on Menopausal Breast (BrAVA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00785317
First received: November 4, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 4, 2008
November 4, 2008
November 2008
October 2009   (final data collection date for primary outcome measure)
Mammographic breast density - classified according to digitized data-based quantification of breast density. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Effects on serum levels of Oestradiol etc. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Estradiol on Menopausal Breast
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hormone Replacement Therapy
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.
  • Experimental: Angemin
    1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP
    Intervention: Drug: Angemin vs Activelle
  • Active Comparator: Activelle
    1 mg of oral E2 in continuous combination with 0.5 mg of NETA
    Intervention: Drug: Angemin vs Activelle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2010
October 2009   (final data collection date for primary outcome measure)

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.
Female
50 Years to 60 Years
Yes
Contact: Eva Lundström +46851770000 eva.lunstrom@karolinska.se
Sweden
 
NCT00785317
080818
No
Eva Lundström, MD, PhD, Karolinska University Hospital
Karolinska Institutet
Not Provided
Not Provided
Karolinska Institutet
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP