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

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ClinicalTrials.gov Identifier: NCT01487304
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Menopause Hormone Replacement Therapy, Post-Menopausal Drug: Marketed low dose hormone replacement therapy

Study Design
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Study Type : Observational
Actual Enrollment : 3760 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Professional Societies Recommendations on Practical Use of Hormone Replacement Therapy - Project "WOMAN 2005"
Study Start Date : April 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Breast tenderness

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

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01487304     History of Changes
Other Study ID Numbers: KLIM-1937
First Posted: December 7, 2011    Key Record Dates
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