Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004076

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004076
  •   2012/08/03
  •   2006/09/08
  •   no
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Secondary IDs

  •   2006-001228-37 
  •   NCT00377793  (ClinicalTrials.gov)
  •   12146  (Bayer)
  •   EudraCT 2006-001228-37 
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Health Condition or Problem studied

  •   Sexual Dysfunction
  •   Male Erectile Dysfunction
  •   N48.4 -  Impotence of organic origin
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Interventions/Observational Groups

  •   Drug: Levitra (Vardenafil, BAY38-9456)
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

- Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life; time frame: 12 weeks

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Secondary Outcome

- SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo; time frame: 24 weeks
- Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo; time frame: 24 weeks
- Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20); time frame: 24 weeks

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Countries of Recruitment

  •   Belgium
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   South Africa
  •   Spain
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Locations of Recruitment

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Recruitment

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  •   2006/07/31
  •   353
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   64   Years
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Additional Inclusion Criteria

- 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

- 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

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Exclusion Criteria

- 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

- 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

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer
    • Bayer Study Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2007/08/01
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.