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Clinical Trials/NCT00785317
NCT00785317UnknownPhase 4

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

Karolinska Institutet1 site in 1 country120 target enrollmentStarted: November 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Enrollment
120
Locations
1
Primary Endpoint
Mammographic breast density - classified according to digitized data-based quantification of breast density.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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/m
  • 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.

Arms & Interventions

Angemin

Experimental

1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP

Intervention: Angemin vs Activelle (Drug)

Activelle

Active Comparator

1 mg of oral E2 in continuous combination with 0.5 mg of NETA

Intervention: Angemin vs Activelle (Drug)

Outcomes

Primary Outcomes

Mammographic breast density - classified according to digitized data-based quantification of breast density.

Time Frame: 6 months

Secondary Outcomes

  • Effects on serum levels of Oestradiol etc.(6 months)

Investigators

Sponsor Class
Other

Study Sites (1)

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