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Effects of Estradiol on Menopausal Breast (BrAVA)

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ClinicalTrials.gov Identifier: NCT00785317
Recruitment Status : Unknown
Verified November 2008 by Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : November 5, 2008
Last Update Posted : November 5, 2008
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated 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 : November 2008
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : April 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. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Effects on serum levels of Oestradiol etc. [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eva Lundström, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00785317     History of Changes
Other Study ID Numbers: 080818
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: November 5, 2008
Last Verified: November 2008

Keywords provided by Karolinska Institutet:
Postmenopausal Hormone Replacement Therapy

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