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Erectile DysfunctionPhase 3NCT00661596

Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 13 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Levitra (Vardenafil, BAY38-9456)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
13 sitesSpain
Study dates
May 2003to Jan 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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 years and older
  • Males with erectile dysfunction
  • Stable heterosexual relationship

Who cannot join

  • Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
  • Nitrate use
  • Other exclusion criteria apply acc. to Summary of Product Characteristics

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Spain13 sites

  • Study site

    Alicante, Alicante, 03010

  • Study site

    Barcelona, Catalonia, 08025

  • Study site

    Granada, Granada, 18003

  • Study site

    Hondarribia, Guipuzcoa, 28280

  • Study site

    Leganés, Madrid, 28911

  • Study site

    Málaga, Málaga, 29010

  • Study site

    Móstoles, Madrid, 28935

  • Study site

    Oviedo, Principality of Asturias, 33006

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Seville, Sevilla, 41071

  • Study site

    Valencia, Valencia, 46014

  • Study site

    Valladolid, Valladolid, 47011

  • Study site

    Vigo, Pontevedra, 36211

Other trials in Spain

About this study

Official title: Multi-centre, Randomised, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-esteem and Self-confidence in Patients With Erectile Dysfunction

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Being tested
Levitra (Vardenafil, BAY38-9456), Placebo
Keywords
Erectile Dysfunction, Vardenafil
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levitra (Vardenafil, BAY38-9456)Drug

    5 mg, 10 mg and 20 mg one hour prior to sexual intercourse

  • PlaceboDrug

    Matching placebo

Study groups in NCT00661596
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Levitra (Vardenafil, BAY38-9456)
Arm 2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Index of Erectile Function - Erectile Function Domain

    Measured: 12 weeks

Secondary outcomes (4)

  1. Global Assessment Questionnaire

    Measured: 12 weeks

  2. IIEF-EF domain score

    Measured: 12 weeks

  3. Other diary based variables

    Measured: 12 weeks

  4. Safety and tolerability

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2008 (estimated)
  2. Study startMay 2003
  3. Primary completionJan 2004
  4. Study completionJan 2004

Resources

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
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00661596
Sponsor's protocol ID
11139
Status last verified
Dec 2014
First submitted
15 Apr 2008
Last updated
30 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 13 sites in Spain.

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 3 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: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

International Index of Erectile Function - Erectile Function Domain (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00661596.

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 30 Dec 2014.

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