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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
  Purpose

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 Intervention Phase
Hormone Replacement Therapy
Drug: Angemin vs Activelle
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Mammographic breast density - classified according to digitized data-based quantification of breast density. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects on serum levels of Oestradiol etc. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785317

Contacts
Contact: Eva Lundström +46851770000 eva.lunstrom@karolinska.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Principal Investigator: Eva Lundström         
Sponsors and Collaborators
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Eva Lundström, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00785317     History of Changes
Other Study ID Numbers: 080818
Study First Received: November 4, 2008
Last Updated: November 4, 2008
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
Postmenopausal Hormone Replacement Therapy

Additional relevant MeSH terms:
Estrogens
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014