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Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations

NCT00184795 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2017-02-23

No results posted yet for this study

Summary

This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.

Conditions

Interventions

DRUG

0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

One tablet per day for 24 weeks

DRUG

0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)

One tablet per day for 24 weeks

DRUG

placebo

Placebo tablets for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-28
Primary Completion
2005-05-04
Completion
2005-05-04

Countries

  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Norway
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00184795 on ClinicalTrials.gov