Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sexual Dysfunction; Male Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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 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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life
Secondary outcome: SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placeboAdditional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20)
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Male.
Criteria:
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
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
Locations and Contacts
Bruxelles - Brussel 1000, Belgium
Genk 3600, Belgium
Leuven 3000, Belgium
Liege 4000, Belgium
Roeselare 8800, Belgium
La Rochelle 17000, France
Lille 59000, France
Lyon 69000, France
Marseille 13009, France
Marseille 13275, France
Mont-de-marsan 40000, France
Paris 75009, France
Toulouse 31000, France
Bergamo 24128, Italy
Firenze 50139, Italy
Milano 20132, Italy
Napoli 80131, Italy
Roma 00155, Italy
Arnhem 6836 BH, Netherlands
Deventer 7415 EH, Netherlands
Enschede 7511 JX, Netherlands
Nijverdal 7442 LS, Netherlands
Alicante 03010, Spain
Barcelona 08034, Spain
Valencia 46010, Spain
La Roca del Vallès, Barcelona 08430, Spain
Barcelona, Cataluña 08025, Spain
Bloemfontein, Free State 9324, South Africa
Johannesburg, Gauteng 2090, South Africa
Hamburg, Hamburg / 287 20251, Germany
Hamburg, Hamburg / 287 20354, Germany
Hamburg, Hamburg / 287 22177, Germany
Newcastle, Kwa Zulu-Natal 2940, South Africa
Durban, KwaZulu Natal 4037, South Africa
Durban, KwaZulu Natal 4091, South Africa
Hannover, Niedersachsen / 291 30625, Germany
Brühl, Nordrhein-Westfalen / 325 50321, Germany
Mülheim, Nordrhein-Westfalen / 481 45468, Germany
Wuppertal, Nordrhein-Westfalen / 616 42103, Germany
Vigo, Pontevedra 36211, Spain
Bautzen, Sachsen / 313 02625, Germany
Dresden, Sachsen / 313 01129, Germany
Leipzig, Sachsen / 313 04105, Germany
Leisnig, Sachsen / 313 04703, Germany
Meißen, Sachsen / 313 01662, Germany
Wahlstedt, Schleswig-Holstein / 306 23812, Germany
La Laguna, Tenerife 38320, Spain
Additional Information
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Starting date: July 2006
Last updated: December 23, 2014
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