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 - PARTNER II
- Conditions
- Males with Erectile Dysfunction
- Registration Number
- EUCTR2006-001228-37-BE
- Lead Sponsor
- Bayer HealthCare AG, D-51368 Leverkusen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subject:
•Males known to have had ED for at least six months
•Stable, heterosexual relationship for more than 6 months.
•Men, 18-64 years of age.
•Documented, dated, written Informed Consent.
•The subject and his female partner must make at least four attempts at sexual intercourse on four separate days during the untreated baseline period
•At least 50% of attempts at sexual intercourse during the untreated baseline period must be unsuccessful.
Partner:
•Women, 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 FSFI > 23.55.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Subject:
A)Previous or current medical conditions
•Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study.
•Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie’s disease) which, in the Investigator’s opinion, would significantly impair sexual performance.
•Primary hypoactive sexual desire.
•Spinal cord injury.
•History of surgical prostatectomy (transurethral interventions not excluded).
•Hereditary degenerative retinal disorders such as retinitis pigmentosa.
•Loss of vision of one eye because of NAION.
•Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity.
•History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
•Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate = 100 bpm).
•Severe chronic or acute liver disease (Child-Pugh B), history of moderate or severe (Child-Pugh C) hepatic impairment.
•Clinically significant chronic haematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma and leukemia.
•Bleeding disorder.
•Significant active peptic ulceration.
•Resting hypotension (a resting systolic blood pressure of < 90 mm Hg) or hypertension (a resting systolic blood pressure > 170 mm Hg or a resting diastolic blood pressure > 110 mm Hg).
•History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
•History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.
•Symptomatic postural hypotension within 6 months of Visit 1.
B) Concomitant medication
•Subjects who are taking nitrates or nitric oxide donors.
•Subjects who are taking oral or injectable androgens.
•Subjects who are taking anti-androgens.
•Subjects who are taking the following potent inhibitors of cytochrome P450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.
•Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1.
•Use of any treatment for ED within 7 days of Visit 1 or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
•Subjects who are taking alpha-blockers at Visit 1.
C) Abnormal laboratory values
•Subjects who have a serum total testosterone level more than 25% below the age-adjusted lower limit of normal according to the range of the testing laboratory.
•Subjects with a serum creatinine clearance (calculated) < 30.0 mg/mL.
•Elevation of AST and/or ALT > 3 times the upper limit of normal.
Partner:
•Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;<br> Primary end point(s): Eficacy:<br> The primary measures of efficacy in this study will be improved success of erection maintenance in men with ED and improvement in female partner’s sexual quality of life after 12 weeks of randomized treatment.<br> ;<br> Main Objective: The primary objective of this study is to compare the efficacy of vardenafil flexible dose after 12 weeks of treatment versus placebo in terms of:<br> 1. Success of maintenance of erection in men with ED.<br> and<br> 2. Improvement of their female partner’s sexual quality of life.<br><br>
- Secondary Outcome Measures
Name Time Method