MenopausePhase 3NCT00560924
Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women
A Phase 3 study testing estradiol, 25 mcg in people with Menopause and Urinary Infections, run by Novo Nordisk A/S at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Menopause, Urinary Infections
- What is being tested?
- estradiol, 25 mcg
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 21 Mar 2003to 17 Mar 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-menopausal woman with Urogenital ageing (UGA)
- Recurrent urinary tract infections defined as three or more urinary tract infections within the past twelve months
Who cannot join
- Known or suspected allergy to trial product or related products
- Present UTI
- History of RUTI during fertile period of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women (RUTI) in Post-menopausal Women With Signs of Urogenital Ageing (UGA)
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).
- Conditions
- Menopause, Urinary Infections
- Being tested
- estradiol, 25 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol, 25 mcgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first symptom of urinary tract infection (UTI)
Secondary outcomes (1)
Number of urinary tract infection (UTI)
Measured: During the 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study start21 Mar 2003
- Primary completion17 Mar 2004
- Study completion17 Mar 2004
Why it stopped: Trial prematurely discontinued due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560924
- Sponsor's protocol ID
- VAG-1458
- Status last verified
- Feb 2017
- First submitted
- 19 Nov 2007
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women (RUTI) in Post-menopausal Women With Signs of Urogenital Ageing (UGA)
- ClinicalTrials.gov ID
- NCT00560924
- Acronym / sponsor ID
- VAG-1458
- Conditions
- Menopause, Urinary Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial prematurely discontinued due to slow recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2003 (actual)
- Primary completion
- 17 Mar 2004 (actual)
- Study completion
- 17 Mar 2004 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Post-menopausal woman with Urogenital ageing (UGA)
- Recurrent urinary tract infections defined as three or more urinary tract infections within the past twelve months
Key exclusion criteria (3 listed)
- Known or suspected allergy to trial product or related products
- Present UTI
- History of RUTI during fertile period of life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estradiol, 25 mcg | Drug | – |
Primary outcome
Time to first symptom of urinary tract infection (UTI)
1 secondary outcome
Number of urinary tract infection (UTI)
Time frame: During the 12 months of treatment
Results and safety
The study was stopped early (reason given: Trial prematurely discontinued due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing estradiol, 25 mcg in people with Menopause and Urinary Infections, run by Novo Nordisk A/S at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial prematurely discontinued due to slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first symptom of urinary tract infection (UTI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.