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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00377793
Collaborator
(none)
352
Enrollment
47
Locations
2
Arms
13
Duration (Months)
7.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Levitra (Vardenafil, BAY38-9456)
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
352 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2006
Actual Study Completion Date :
Aug 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)
Placebo Comparator: Arm 2

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life [12 weeks]

Secondary Outcome Measures

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bruxelles - Brussel Belgium 1000
2 Genk Belgium 3600
3 Leuven Belgium 3000
4 Liege Belgium 4000
5 Roeselare Belgium 8800
6 La Rochelle France 17000
7 Lille France 59000
8 Lyon France 69000
9 Marseille France 13009
10 Marseille France 13275
11 Mont-de-marsan France 40000
12 Paris France 75009
13 Toulouse France 31000
14 Hamburg Hamburg / 287 Germany 20251
15 Hamburg Hamburg / 287 Germany 20354
16 Hamburg Hamburg / 287 Germany 22177
17 Hannover Niedersachsen / 291 Germany 30625
18 Brühl Nordrhein-Westfalen / 325 Germany 50321
19 Mülheim Nordrhein-Westfalen / 481 Germany 45468
20 Wuppertal Nordrhein-Westfalen / 616 Germany 42103
21 Bautzen Sachsen / 313 Germany 02625
22 Dresden Sachsen / 313 Germany 01129
23 Leipzig Sachsen / 313 Germany 04105
24 Leisnig Sachsen / 313 Germany 04703
25 Meißen Sachsen / 313 Germany 01662
26 Wahlstedt Schleswig-Holstein / 306 Germany 23812
27 Bergamo Italy 24128
28 Firenze Italy 50139
29 Milano Italy 20132
30 Napoli Italy 80131
31 Roma Italy 00155
32 Arnhem Netherlands 6836 BH
33 Deventer Netherlands 7415 EH
34 Enschede Netherlands 7511 JX
35 Nijverdal Netherlands 7442 LS
36 Bloemfontein Free State South Africa 9324
37 Johannesburg Gauteng South Africa 2090
38 Newcastle Kwa Zulu-Natal South Africa 2940
39 Durban KwaZulu Natal South Africa 4037
40 Durban KwaZulu Natal South Africa 4091
41 La Roca del Vallès Barcelona Spain 08430
42 Barcelona Cataluña Spain 08025
43 Vigo Pontevedra Spain 36211
44 La Laguna Tenerife Spain 38320
45 Alicante Spain 03010
46 Barcelona Spain 08034
47 Valencia Spain 46010

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00377793
Other Study ID Numbers:
  • 12146
  • EudraCT 2006-001228-37
First Posted:
Sep 18, 2006
Last Update Posted:
Dec 24, 2014
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:
Erectile Dysfunction
Vardenafil Dihydrochloride

Study Results

No Results Posted as of Dec 24, 2014