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AzTrials

Erectile DysfunctionPhase 3LUTECIANCT00668109

Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) and Tadalafil in people with Erectile Dysfunction, run by Bayer at 74 sites in 13 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

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia 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) and Tadalafil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
614 participants
Where
74 sitesin 13 countries
Study dates
Dec 2003to Jun 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

Inclusion Criteria:- Age: 18 years and older- Males with erectile dysfunction- Stable heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use- Other exclusion criteria apply according to Summary of Product Characteristics

Trial locations and contacts

74 sites in 13 countries.

74 sites in 13 countries

Germany15 sites

  • Study site

    Berlin, State of Berlin, 13125

  • Study site

    Berlin, State of Berlin, 13347

  • Study site

    Berlin, State of Berlin, 13465

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20354

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Königsbrunn, Bavaria, 86343

  • Study site

    Marburg, Hesse, 35039

  • Study site

    Mönchengladbach, North Rhine-Westphalia, 41061

  • Study site

    München, Bavaria, 80333

  • Study site

    München, Bavaria, 81925

  • Study site

    Osnabrück, Lower Saxony, 49076

  • Study site

    Stuttgart, Baden-Wurttemberg, 70372

  • Study site

    Weiden, Bavaria, 92637

  • Study site

    Westerstede, Lower Saxony, 26655

Other trials in Germany

South Africa10 sites

  • Study site

    Cape Town, Western Cape, 7505

  • Study site

    Cape Town, Western Cape, 7800

  • Study site

    Durban, KwaZulu-Natal, 3630

  • Study site

    Durban, KwaZulu-Natal, 4000

  • Study site

    Durban, KwaZulu-Natal, 4091

  • Study site

    George, Eastern Cape, 6530

  • Study site

    Johannesburg, Gauteng, 2193

  • Study site

    Newcastle, KwaZulu-Natal, 2940

  • Study site

    Pietermaritzburg, KwaZulu-Natal, 3200

  • Study site

    Pretoria, Gauteng, 0083

Other trials in South Africa

Italy8 sites

  • Study site

    Catania, 95124

  • Study site

    Milan, 20123

  • Study site

    Milan, 20132

  • Study site

    Milan, 20142

  • Study site

    Padova, 35128

  • Study site

    Pavia, 27100

  • Study site

    Perugia, 06126

  • Study site

    Pisa, 56126

Other trials in Italy

Spain8 sites

  • Study site

    A Coruña, A Coruña, 15006

  • Study site

    Castellon, Castellón de La Plana, 12004

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Málaga, Málaga, 29010

  • Study site

    Palma de Mallorca, Palma de Mallorca, 07014

  • Study site

    Sant Joan d'Alacant, Alicante, 03550

  • Study site

    Vigo, Pontevedra, 36211

  • Study site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Mexico6 sites

  • Study site

    Durango, Durango, 34000

  • Study site

    Iguala de la Independencia, Guerrero, 40000

  • Study site

    México, D. F., México, D. F., 06700

  • Study site

    México, D.F., 14050

  • Study site

    México, D.F., 14080

  • Study site

    Monterrey, Nuevo León, 66260

Other trials in Mexico

Belgium4 sites

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Edegem, 2650

  • Study site

    Roeselare, 8800

Other trials in Belgium

Colombia4 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Medellín

  • Study site

    Santa Fé de Bogotá

Other trials in Colombia

Israel4 sites

  • Study site

    Haifa, Israel, 31096

  • Study site

    Jerusalem, Israel, 91120

  • Study site

    Tel Aviv, Israel, 64239

  • Study site

    Tel HaShomer, 52621

Other trials in Israel

Norway4 sites

  • Study site

    Moelv, 2390

  • Study site

    Oslo, 0272

  • Study site

    Sarpsborg, 1700

  • Study site

    Trondheim, 7006

Other trials in Norway

Finland3 sites

  • Study site

    Helsinki, 00100

  • Study site

    Helsinki, 00180

  • Study site

    Oulu, 90100

Other trials in Finland

Peru3 sites

  • Study site

    Callao, CALLAO 2

  • Study site

    Lima, 33

  • Study site

    Lima, LIMA 27

Other trials in Peru

Sweden3 sites

  • Study site

    Borås, 503 32

  • Study site

    Skövde, 541 30

  • Study site

    Stockholm, 171 76

Other trials in Sweden

Netherlands2 sites

  • Study site

    Nijverdal, 7442 LS

  • Study site

    Utrecht, 3514 AB

Other trials in Netherlands

About this study

Official title: A Randomized, Open-label, Multi-center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

Being tested
Levitra (Vardenafil, BAY38-9456), Tadalafil
Keywords
Erectile Dysfunction, Diabetes mellitus, Hypertension, Hyperlipidemia, Vardenafil
Medical subject headings
Erectile Dysfunction, Diabetes Mellitus, Hypertension, Hyperlipidemias

What participants receive

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

  • Levitra (Vardenafil, BAY38-9456)Drug

    10 mg one hour prior to sexual intercourse

  • TadalafilDrug

    10 mg taken approximately 24 hours prior to sexual intercourse

Study groups in NCT00668109
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Levitra (Vardenafil, BAY38-9456)
Arm 2Active comparatorNot described
Receives: Drug: Tadalafil

What is being measured

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

  1. Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group

    Measured: 4 weeks

Secondary outcomes (4)

  1. Sexual encounter profile question 2

    Measured: 4 weeks

  2. Hardness of erection

    Measured: 4 weeks

  3. Other diary based variables

    Measured: 4 weeks

  4. Safety and tolerability

    Measured: 4 weeks

Timeline

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

  1. First posted28 Apr 2008 (estimated)
  2. Study startDec 2003
  3. Primary completionJun 2004
  4. Study completionJun 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
None (open label)
Enrolment
614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00668109
Sponsor's protocol ID
10893
Acronym
LUTECIA
Status last verified
Dec 2014
First submitted
24 Apr 2008
Last updated
23 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) and Tadalafil in people with Erectile Dysfunction, run by Bayer at 74 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 23 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 74 sites in Germany, South Africa, Italy, Spain, Mexico and 8 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. 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?

Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group (time frame: 4 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 NCT00668109.

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 23 Dec 2014.

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