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Impact of Professional Societies' Recommendations on Practical Use of Hormone Replacement Therapy
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01487304
First received: December 5, 2011
Last updated: October 14, 2016
Last verified: October 2016
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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
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| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01487304
Please refer to this study by its ClinicalTrials.gov identifier: 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:
| Responsible Party: | 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: | October 14, 2016 |
Additional relevant MeSH terms:
|
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 27, 2017