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Erectile DysfunctionPhase 3NCT00665496

A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 75 sites in 11 countries.

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

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. 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)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
732 participants
Where
75 sitesin 11 countries
Study dates
Jun 2003to Nov 2003
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

  • Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
  • Heterosexual relationship
  • 18 years and older

Who cannot join

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
  • Nitrates or nitric oxide donors use
  • Other exclusion criteria according to the US Product Information

Trial locations and contacts

75 sites in 11 countries.

75 sites in 11 countries

Germany13 sites

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40210

  • Study site

    Garmisch-Partenkirchen, Bavaria, 82467

  • Study site

    Halle, Saxony-Anhalt, 06097

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20354

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Leipzig, Saxony, 04105

  • Study site

    Marburg, Hesse, 35039

  • Study site

    Mönchengladbach, North Rhine-Westphalia, 41061

  • Study site

    München, Bavaria, 80333

  • Study site

    München, Bavaria, 81925

  • Study site

    Niederkassel, North Rhine-Westphalia, 53859

  • Study site

    Osnabrück, Lower Saxony, 49076

  • Study site

    Westerstede, Lower Saxony, 26655

Other trials in Germany

United States12 sites

  • Study site

    Aurora, Colorado, 80012

  • Study site

    Aventura, Florida, 33180

  • Study site

    Beverly Hills, California, 90212

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Jacksonville, Florida, 32257

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    New York, New York, 10016

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Phoenix, Arizona, 85023

  • Study site

    San Bernardino, California, 92404

  • Study site

    Trumbull, Connecticut, 06611

  • Study site

    Wilmington, North Carolina, 28401

Other trials in United States

Canada8 sites

  • Study site

    Barrie, Ontario, L4M 4S5

  • Study site

    Calgary, Alberta, T3G 3J9

  • Study site

    Kentville, Nova Scotia, B4N 4K9

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Saint John, New Brunswick, E2L 3J8

  • Study site

    Sherbrooke, Quebec, J1H 5N4

  • Study site

    Toronto, Ontario, M4C 3E7

  • Study site

    Winnipeg, Manitoba, R3T 5J3

Other trials in Canada

France8 sites

  • Study site

    Carpentras, 84200

  • Study site

    Lille, 59000

  • Study site

    Lyon, 69000

  • Study site

    Lyon, 69437

  • Study site

    Marseille, 13275

  • Study site

    Montpellier, 34000

  • Study site

    Nîmes, 30000

  • Study site

    Paris, 75015

Other trials in France

Spain8 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Catalonia, 08025

  • Study site

    Castellon, Castellón de La Plana, 12004

  • Study site

    Galdakao, Bizkaia, 48960

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Poland6 sites

  • Study site

    Kościerzyna, 83-400

  • Study site

    Lodz, 91-425

  • Study site

    Poznan, 61-701

  • Study site

    Warsaw, Poland, 04-749

  • Study site

    Warsaw, 01-059

  • Study site

    Wroclaw, 54-144

Other trials in Poland

Italy5 sites

  • Study site

    Milan, 20132

  • Study site

    Milan, 20142

  • Study site

    Modena, 41100

  • Study site

    Naples, 80131

  • Study site

    Padova, 35128

Other trials in Italy

Netherlands5 sites

  • Study site

    Amsterdam, 1061 AE

  • Study site

    Nijmegen, 6525 GA

  • Study site

    Roermond, 6043 CV

  • Study site

    The Hague, 2512 VA

  • Study site

    Utrecht, 3514 AB

Other trials in Netherlands

Norway4 sites

  • Study site

    Moelv, 2390

  • Study site

    Oslo, 0272

  • Study site

    Sarpsborg, 1700

  • Study site

    Trondheim, 7006

Other trials in Norway

Sweden4 sites

  • Study site

    Borås, 503 32

  • Study site

    Gothenburg, 412 59

  • Study site

    Skövde, 541 30

  • Study site

    Stockholm, 171 76

Other trials in Sweden

United Kingdom2 sites

  • Study site

    Bristol, Avon, BS10 5NB

  • Study site

    Bristol, Avon, BS2 8HW

Other trials in United Kingdom

About this study

Official title: A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction.

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

Being tested
Levitra (Vardenafil, BAY38-9456), Placebo
Keywords
Erectile Dysfunction, Vardenafil, Onset of action
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

    Vardenafil 10 mg and 20 mg orally once a day as needed

  • PlaceboDrug

    Matching Placebo

Study groups in NCT00665496
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. - Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3)

    Measured: First four doses with successful intercourse

Secondary outcomes (5)

  1. - Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2).

    Measured: among the first four doses

  2. - The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores.

    Measured: among the first four doses

  3. - Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.

    Measured: among the first four doses

  4. - Other diary questions

    Measured: among the first four doses

  5. - Safety and tolerability

    Measured: within the study duration

Timeline

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

  1. First posted24 Apr 2008 (estimated)
  2. Study startJun 2003
  3. Study completionNov 2003

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
732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00665496
Sponsor's protocol ID
100492
Other IDs
ONTIME
Status last verified
Dec 2014
First submitted
23 Apr 2008
Last updated
17 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 75 sites in 11 countries.

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 4 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 17 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 75 sites in Germany, United States, Canada, France, Spain and 6 more countries. 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?

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3) (time frame: First four doses with successful intercourse). 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 NCT00665496.

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 17 Dec 2014.

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