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

Phase 1

Conditions: Males with Erectile Dysfunction
MedDRA version: 8.1 Level: LLT Classification code 10061461 Term: Erectile dysfunction

Registration Number: EUCTR2006-001228-37-NL

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

Inclusion Criteria

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

Exclusion Criteria

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 mL/min.
•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 Outcome Measures

Name	Time	Method

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