NCT01487304

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,760

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

December 5, 2011

Last Update Submit

October 14, 2016

Conditions

MenopauseHormone Replacement Therapy, Post-Menopausal

Outcome Measures

Primary Outcomes (1)

  • Breast tenderness

Secondary Outcomes (1)

  • Patient treatment satisfaction after switch to low dose HRT

Study Arms (1)

Low dose HRT

Drug: Marketed low dose hormone replacement therapy

Interventions

Marketed low dose hormone replacement therapyDRUG

A low dose of marketed HRT products prescribed at the discretion of the treating physician

Low dose HRT

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Post-menopausal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Prague, Czechia

Location

Related Links

MeSH Terms

Interventions

Hormone Replacement Therapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

April 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

CZ(1)