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Sexual DysfunctionPhase 4NCT00377793

Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II

A Phase 4 study testing Levitra (Vardenafil, BAY38-9456) in people with Sexual Dysfunction and Male Erectile Dysfunction, run by Bayer at 47 sites in 7 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 trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and… Read more about this study

Who is it for?
Ages 18 to 64 years, men only
Conditions the study is for
Sexual Dysfunction, Male 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
352 participants
Where
47 sitesin 7 countries
Study dates
Jul 2006to Aug 2007
Phase
Phase 4
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 to 64 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Males 18 to 64 years
  • Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
  • Stable heterosexual relationship for more than 6 months
  • The subject must make at least four attempts at sexual intercourse
  • Documented, dated, written Informed Consent Inclusion Criteria Partner
  • Females 18 years, and older
Show all 10Show fewer
  • Stable, heterosexual relationship for more than 6 months with male ED subject
  • Documented, dated, written Informed Consent
  • Motivated to support treatment for male partner's ED
  • Absence of significant sexual dysfunction as assessed by the total score on the FSFI16 > 23.55

Who cannot join

  • Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
  • Subjects who are taking nitrates or nitric oxide donors
  • Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents traconazole and ketoconazole (topical forms are allowed) or erythromycin
  • Known hypersensitivity to vardenafil
  • Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
  • History of retinitis pigmentosa
Show all 13Show fewer
  • Unstable angina pectoris
  • Severe chronic or acute liver disease
  • Premature ejaculator (defined as IELT < 2 minutes)
  • Subjects who were taking alpha blockers
  • Lost of vision of one eye because of NAION Exclusion Criteria Partner
  • Presence of sexual dysfunction as assessed by the FSFI16 < 23.55
  • Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the partner's ability to complete the study or precludes the partner's participation in the study

Trial locations and contacts

47 sites in 7 countries.

47 sites in 7 countries

Germany13 sites

  • Study site

    Bautzen, Sachsen / 313, 02625

  • Study site

    Brühl, Nordrhein-Westfalen / 325, 50321

  • Study site

    Dresden, Sachsen / 313, 01129

  • Study site

    Hamburg, Hamburg / 287, 20251

  • Study site

    Hamburg, Hamburg / 287, 20354

  • Study site

    Hamburg, Hamburg / 287, 22177

  • Study site

    Hanover, Niedersachsen / 291, 30625

  • Study site

    Leipzig, Sachsen / 313, 04105

  • Study site

    Leisnig, Sachsen / 313, 04703

  • Study site

    Meißen, Sachsen / 313, 01662

  • Study site

    Mülheim, Nordrhein-Westfalen / 481, 45468

  • Study site

    Wahlstedt, Schleswig-Holstein / 306, 23812

  • Study site

    Wuppertal, Nordrhein-Westfalen / 616, 42103

Other trials in Germany

France8 sites

  • Study site

    La Rochelle, 17000

  • Study site

    Lille, 59000

  • Study site

    Lyon, 69000

  • Study site

    Marseille, 13009

  • Study site

    Marseille, 13275

  • Study site

    Mont-de-Marsan, 40000

  • Study site

    Paris, 75009

  • Study site

    Toulouse, 31000

Other trials in France

Spain7 sites

  • Study site

    Alicante, Alicante, 03010

  • Study site

    Barcelona, Barcelona, 08034

  • Study site

    Barcelona, Catalonia, 08025

  • Study site

    La Roca del Vallès, Barcelona, 08430

  • Study site

    San Cristóbal de La Laguna, Tenerife, 38320

  • Study site

    Valencia, Valencia, 46010

  • Study site

    Vigo, Pontevedra, 36211

Other trials in Spain

Belgium5 sites

  • Study site

    Bruxelles - Brussel, 1000

  • Study site

    Genk, 3600

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

  • Study site

    Roeselare, 8800

Other trials in Belgium

Italy5 sites

  • Study site

    Bergamo, 24128

  • Study site

    Florence, 50139

  • Study site

    Milan, 20132

  • Study site

    Naples, 80131

  • Study site

    Roma, 00155

Other trials in Italy

South Africa5 sites

  • Study site

    Bloemfontein, Free State, 9324

  • Study site

    Durban, KwaZulu-Natal, 4037

  • Study site

    Durban, KwaZulu-Natal, 4091

  • Study site

    Johannesburg, Gauteng, 2090

  • Study site

    Newcastle, KwaZulu-Natal, 2940

Other trials in South Africa

Netherlands4 sites

  • Study site

    Arnhem, 6836 BH

  • Study site

    Deventer, 7415 EH

  • Study site

    Enschede, 7511 JX

  • Study site

    Nijverdal, 7442 LS

Other trials in Netherlands

About this study

Official title: A Randomized, Double Blind, Parallel Group Study of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction and Their Female Partners Sexual Quality of Life. PARTNER II

This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.

Being tested
Levitra (Vardenafil, BAY38-9456), Placebo
Medical subject headings
Sexual Dysfunction, Physiological, 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

  • PlaceboDrug

Study groups in NCT00377793
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. Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life

    Measured: 12 weeks

Secondary outcomes (3)

  1. SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo

    Measured: 24 weeks

  2. Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo

    Measured: 24 weeks

  3. Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20)

    Measured: 24 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 Sep 2006 (estimated)
  2. Study startJul 2006
  3. Study completionAug 2007

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00377793
Sponsor's protocol ID
12146
Other IDs
EudraCT 2006-001228-37
Status last verified
Dec 2014
First submitted
8 Sep 2006
Last updated
24 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levitra (Vardenafil, BAY38-9456) in people with Sexual Dysfunction and Male Erectile Dysfunction, run by Bayer at 47 sites in 7 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 10 inclusion and 13 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 24 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 47 sites in Germany, France, Spain, Belgium, Italy and 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life (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 NCT00377793.

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 24 Dec 2014.

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