Preventive Effect of Treatment With Estradiol Vaginal Tab... | NCT00560924

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

NCT00560924

Sponsor

Novo Nordisk A/S

Status

Terminated

Last Update Posted

Feb 28, 2017Actual

Enrollment

6Actual

Phase

Phase 3

Conditions

Menopause
Urinary Infections

Interventions

estradiol, 25 mcg

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Trial prematurely discontinued due to slow recruitment

Expanded Access Info

Start Date

Mar 21, 2003Actual

Primary Completion Date

Mar 17, 2004Actual

Completion Date

Mar 17, 2004Actual

First Submitted Date

Nov 19, 2007

First Submission Date that Met QC Criteria

Nov 19, 2007

First Posted Date

Nov 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2017

Last Update Posted Date

Feb 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Name	Type	Description	Arm Group Labels	Other Names
estradiol, 25 mcg	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first symptom of urinary tract infection (UTI)

Secondary Outcomes

Measure	Description	Time Frame
Number of urinary tract infection (UTI)		During the 12 months of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Malmö		205 02	Sweden

Label	URL
Clinical Trials at Novo Nordisk	View source

Intervention Browse Module

MeSH Terms

ID	Term
D004958	Estradiol

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided