A randomized, explorative, double-blind, double-dummy, multi-center, parallel group study to assess sustainable efficacy of once daily vardenafil (10 mg) for 12 and 24 weeks versus vardenafil PRN in men with mild or mild to moderate erectile dysfunction - RESTORE

• Conditions: Erectile Dysfunction; Classification code 10061461

• Registration Number: EUCTR2005-001678-28-DE
• Lead Sponsor: Bayer Healthcare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-02
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 267

Inclusion Criteria

Males 18-64 years of age
Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
Stable, heterosexual relationship for more than six months
Documented, signed and dated written Informed Consent

Are the trial subjects under 18? no
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 (e.g. penile fibrosis or Peyronie’s disease) in the opinion of the Investigator would significantly impair sexual performance
Primary hypoactive sexual desire
Spinal cord injury
History of glaucoma
History of surgical prostatectomy (transurethral intervention not excluded)
Hereditary degenerative retinal disorders such as retinitis pigmentosa
History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C
Known severe chronic or acute liver disease, including history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia
Clinically significant bleeding disorder
Significant active peptic ulceration
Any underlying cardiovascular condition including e.g. unstable angina pectoris or ventricular failure NYHA stages III or IV, that would preclude sexual activity; symptomatic angina pectoris
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)
Resting hypotension (a resting systolic blood pressure of <90 mm Hg or diastolic blood pressure of < 50 mmHg)
Insufficiently controlled hypertension: In patients known to be hypertensive, hypertension has to be sufficiently controlled with antihypertensives in the opinion of the physician treating the hypertension. In addtion, resting blood pressure at visit 1 (singular measurement not appropriate to judge on control of hypertension) must not be >170 mmHg (systolic) or > 110 mmHg (diastolic) irrespective of a patient having been classified as hypertensive or not.
Symptomatic postural hypotension within six months of Visit 1
History of malignancy within the past 5 years (other than squamous or basal cell skin cancer)
Life expectancy <3 years
Clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h).
Diabetes mellitus type 1

B) Concomitant Medication
Nitrates or nitric oxide donors
Oral or injectable or transdermally applied androgens
Anti-androgens
Anti-coagulants, with the exception of anti-platelet agents
Any of the following potent inhibitors of cytochrome P- 450 3A4:
potent inhibitors: HIV protease inhibitors (indinavir, nelfinavir, ritonavir, atazanavir, lopinavir, amprenavir, saquinavir), makrolid/-ketolid antibiotics (clarithromycin, erythromycin, telithromycin), anti-mycotic agents (itraconazole, ketoconazole [topical forms are allowed]), anti-depressants (nefazodon)
less potent inhibitors: quinupristin/-dalfupristin, fluconazol, amiodaron, diltiazem, fluvoxamin, verapamil, valproinic acid, fluoxetin; grapefruit juice
Any investigational drug (including placebo) within 30 days of Visit 1
Any treatment for ED other than study medication during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
Alpha blockers during randomised treatment and wash-out.

C) Abnormal Laboratory Values
Serum total testosterone level >25% below the lower limit of normal (according to the range of the testing

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified