NCT00560924

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the preventive effect of treatment with estradiol vaginal tablets on recurrent urinary tract infections (RUTI) in post-menopausal women with signs of urogenital ageing (UGA).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

March 21, 2003

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

12 months

First QC Date

November 19, 2007

Last Update Submit

February 24, 2017

Conditions

MenopauseUrinary Infections

Outcome Measures

Primary Outcomes (1)

  • Time to first symptom of urinary tract infection (UTI)

Secondary Outcomes (1)

  • Number of urinary tract infection (UTI)

    During the 12 months of treatment

Interventions

estradiol, 25 mcgDRUG

Eligibility Criteria

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

You may qualify if:

  • Post-menopausal woman with Urogenital ageing (UGA)
  • Recurrent urinary tract infections defined as three or more urinary tract infections within the past twelve months

You may not qualify if:

  • Known or suspected allergy to trial product or related products
  • Present UTI
  • History of RUTI during fertile period of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Malmo, 205 02, Sweden

Location

Related Links

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

March 21, 2003

Primary Completion

March 17, 2004

Study Completion

March 17, 2004

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

SE(1)