Effects of Estradiol on Menopausal Breast - Full Text View

Sponsor:	Karolinska Institutet
Information provided by:	Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00785317

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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:

MedlinePlus related topics: Hormone Replacement Therapy

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

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
Angemin: Experimental 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.
Activelle: Active Comparator 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

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

Keywords provided by Karolinska Institutet:

Postmenopausal Hormone Replacement Therapy

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate

Reproductive Control Agents
Hormones
Estradiol
Pharmacologic Actions
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate

ClinicalTrials.gov processed this record on February 08, 2010