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

Primary Purpose

Sexual Dysfunction, Male Erectile Dysfunction

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo
Additional 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)

Full Information

First Posted
September 8, 2006
Last Updated
December 23, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00377793
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Male Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo
Time Frame
24 weeks
Title
Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo
Time Frame
24 weeks
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
City
Genk
ZIP/Postal Code
3600
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
City
La Rochelle
ZIP/Postal Code
17000
Country
France
City
Lille
ZIP/Postal Code
59000
Country
France
City
Lyon
ZIP/Postal Code
69000
Country
France
City
Marseille
ZIP/Postal Code
13009
Country
France
City
Marseille
ZIP/Postal Code
13275
Country
France
City
Mont-de-marsan
ZIP/Postal Code
40000
Country
France
City
Paris
ZIP/Postal Code
75009
Country
France
City
Toulouse
ZIP/Postal Code
31000
Country
France
City
Hamburg
State/Province
Hamburg / 287
ZIP/Postal Code
20251
Country
Germany
City
Hamburg
State/Province
Hamburg / 287
ZIP/Postal Code
20354
Country
Germany
City
Hamburg
State/Province
Hamburg / 287
ZIP/Postal Code
22177
Country
Germany
City
Hannover
State/Province
Niedersachsen / 291
ZIP/Postal Code
30625
Country
Germany
City
Brühl
State/Province
Nordrhein-Westfalen / 325
ZIP/Postal Code
50321
Country
Germany
City
Mülheim
State/Province
Nordrhein-Westfalen / 481
ZIP/Postal Code
45468
Country
Germany
City
Wuppertal
State/Province
Nordrhein-Westfalen / 616
ZIP/Postal Code
42103
Country
Germany
City
Bautzen
State/Province
Sachsen / 313
ZIP/Postal Code
02625
Country
Germany
City
Dresden
State/Province
Sachsen / 313
ZIP/Postal Code
01129
Country
Germany
City
Leipzig
State/Province
Sachsen / 313
ZIP/Postal Code
04105
Country
Germany
City
Leisnig
State/Province
Sachsen / 313
ZIP/Postal Code
04703
Country
Germany
City
Meißen
State/Province
Sachsen / 313
ZIP/Postal Code
01662
Country
Germany
City
Wahlstedt
State/Province
Schleswig-Holstein / 306
ZIP/Postal Code
23812
Country
Germany
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Firenze
ZIP/Postal Code
50139
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Roma
ZIP/Postal Code
00155
Country
Italy
City
Arnhem
ZIP/Postal Code
6836 BH
Country
Netherlands
City
Deventer
ZIP/Postal Code
7415 EH
Country
Netherlands
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
City
Nijverdal
ZIP/Postal Code
7442 LS
Country
Netherlands
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9324
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2090
Country
South Africa
City
Newcastle
State/Province
Kwa Zulu-Natal
ZIP/Postal Code
2940
Country
South Africa
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4037
Country
South Africa
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4091
Country
South Africa
City
La Roca del Vallès
State/Province
Barcelona
ZIP/Postal Code
08430
Country
Spain
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36211
Country
Spain
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

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

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