Clinical trial NCT00377793: Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sexual Dysfunction
Male Erectile Dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-09-18
Enrollment: 352
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo
timeFrame: 24 weeks
measure: Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo
timeFrame: 24 weeks
measure: Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bruxelles - Brussel
country: Belgium
city: Genk
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Roeselare
country: Belgium
city: La Rochelle
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Mont-de-marsan
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Hamburg
country: Germany
state: Hamburg / 287
city: Hamburg
country: Germany
state: Hamburg / 287
city: Hamburg
country: Germany
state: Hamburg / 287
city: Hannover
country: Germany
state: Niedersachsen / 291
city: Brühl
country: Germany
state: Nordrhein-Westfalen / 325
city: Mülheim
country: Germany
state: Nordrhein-Westfalen / 481
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen / 616
city: Bautzen
country: Germany
state: Sachsen / 313
city: Dresden
country: Germany
state: Sachsen / 313
city: Leipzig
country: Germany
state: Sachsen / 313
city: Leisnig
country: Germany
state: Sachsen / 313
city: Meißen
country: Germany
state: Sachsen / 313
city: Wahlstedt
country: Germany
state: Schleswig-Holstein / 306
city: Bergamo
country: Italy
city: Firenze
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Roma
country: Italy
city: Arnhem
country: Netherlands
city: Deventer
country: Netherlands
city: Enschede
country: Netherlands
city: Nijverdal
country: Netherlands
city: Bloemfontein
country: South Africa
state: Free State
city: Johannesburg
country: South Africa
state: Gauteng
city: Newcastle
country: South Africa
state: Kwa Zulu-Natal
city: Durban
country: South Africa
state: KwaZulu Natal
city: Durban
country: South Africa
state: KwaZulu Natal
city: La Roca del Vallès
country: Spain
state: Barcelona
city: Barcelona
country: Spain
state: Cataluña
city: Vigo
country: Spain
state: Pontevedra
city: La Laguna
country: Spain
state: Tenerife
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: