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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01487304
First received: December 5, 2011
Last updated: May 24, 2012
Last verified: May 2012
  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 [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
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 August 18, 2014