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:

MedlinePlus related topics: Hormone Replacement Therapy Hormones

U.S. FDA Resources

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:

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 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

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