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Impact of Professional Societies' Recommendations on Practical Use of Hormone Replacement Therapy

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: December 5, 2011
Last updated: October 14, 2016
Last verified: October 2016
This study is conducted in Europe. The aim of this study is to verify the therapeutic effects of low-dose hormone replacement therapy (HRT) in female patients over adequately long time period in normal clinical practice conditions in the Czech Republic.

Condition Intervention
Hormone Replacement Therapy, Post-Menopausal
Drug: Marketed low dose hormone replacement therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Professional Societies Recommendations on Practical Use of Hormone Replacement Therapy - Project "WOMAN 2005"

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Breast tenderness

Secondary Outcome Measures:
  • Patient treatment satisfaction after switch to low dose HRT

Enrollment: 3760
Study Start Date: April 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Low dose HRT Drug: Marketed low dose hormone replacement therapy
A low dose of marketed HRT products prescribed at the discretion of the treating physician


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Post-menopausal women suffering from climacteric symptoms who could benefit a switch from standard therapy to low dose therapy at the discretion of the individual physician

Inclusion Criteria:

  • Post-menopausal
  Contacts and Locations
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Please refer to this study by its identifier: NCT01487304

Czech Republic
Novo Nordisk Investigational Site
Prague, Czech Republic
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01487304     History of Changes
Other Study ID Numbers: KLIM-1937
Study First Received: December 5, 2011
Last Updated: October 14, 2016

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on April 25, 2017