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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01487304
First Posted: December 7, 2011
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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
Menopause 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

  Eligibility

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Post-menopausal
  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): NCT01487304


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01487304     History of Changes
Other Study ID Numbers: KLIM-1937
First Submitted: December 5, 2011
First Posted: December 7, 2011
Last Update Posted: October 17, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs