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NCT01487304 Clinical Trial

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

Menopause Clinical Trial

Official title:
Impact of Professional Societies Recommendations on Practical Use of Hormone Replacement Therapy - Project "WOMAN 2005"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01487304
Other study ID # KLIM-1937
Secondary ID
Status Completed
Phase N/A
First received December 5, 2011
Last updated October 14, 2016
Start date April 2005
Est. completion date June 2006

Study information
Verified date October 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug Control
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 3760
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Post-menopausal

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Hormone Replacement Therapy, Post-Menopausal
  • Menopause

Intervention

Drug:
• Marketed low dose hormone replacement therapy
A low dose of marketed HRT products prescribed at the discretion of the treating physician

Locations
Country Name City State
Czech Republic Novo Nordisk Investigational Site Prague

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Czech Republic, 

Outcome
Type Measure Description Time frame Safety issue
Primary Breast tenderness No
Secondary Patient treatment satisfaction after switch to low dose HRT No
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