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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 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)

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

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Click here to find results for studies related to Bayer Healthcare products.

Starting date: July 2006
Last updated: December 23, 2014

Page last updated: August 23, 2015

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