CClinicalTrials.gg
TerminatedNCT00560924Updated Feb 28, 2017

Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women

A Phase 3 interventional study of estradiol, 25 mcg in Menopause and Urinary Infections, sponsored by Novo Nordisk A/S. Terminated at 1 site in Sweden. Open to female participants. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Why this study was terminated
Trial prematurely discontinued due to slow recruitment

From the registry’s dates

  • Registered 4 years 7 months after the study started (first participant enrolled Mar 2003, registered Nov 2007).
Phase
Phase 3
Study type
Interventional
Enrollment
6
Allocation
Randomized
Sex
Female
01

Study 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).

02

Conditions studied

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 6 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Present UTI
  • History of RUTI during fertile period of life
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
6 participants (actual)

Interventions

  • Drugestradiol, 25 mcg
06

What researchers measure

Primary outcomes

  1. Time to first symptom of urinary tract infection (UTI)

Secondary outcomes

  1. Number of urinary tract infection (UTI)

    Time frame: During the 12 months of treatment

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Study locations

1 site
  • Novo Nordisk Investigational Site
    Malmö, 205 02, Sweden
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00560924
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Nov 20, 2007
Start date
Mar 21, 2003
Primary completion
Mar 17, 2004
Completion
Mar 17, 2004
Last update
Feb 28, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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