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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01487304
First received: December 5, 2011
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Breast tenderness [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient treatment satisfaction after switch to low dose HRT [ Designated as safety issue: No ]

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487304

Locations
Czech Republic
Prague, Czech Republic
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Karel Rychna Novo Nordisk s.r.o.
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01487304     History of Changes
Other Study ID Numbers: KLIM-1937
Study First Received: December 5, 2011
Last Updated: May 24, 2012
Health Authority: Czech Republic: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on May 23, 2013