A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction. - S024
- Conditions
- Erectile DysfunctionMedDRA version: 9.1Level: LLTClassification code 10052003Term: Erectile dysfunction NOS
- Registration Number
- EUCTR2008-001055-21-GB
- Lead Sponsor
- Eli Lilly and Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 360
[1] Are male and at least 18 years of age at Visit 1.
[2] Are able to read, understand and provide informed consent.
[3] Have history of erectile dysfunction (ED) based on the disease diagnostic criteria (Protocol Section 4.1.1).
[4] Have had satisfactory response (in the opinion of the investigator) to an oral PDE5 inhibitor PRN (tadalafil, sildenafil citrate, or vardenafil HCl) for treatment of ED, for a period of at least 6 months, at an average minimum frequency of 1 dose per week.
[5] Anticipate frequent use (at least one dose per week, on average) of PDE5 inhibitors when administered PRN during the study.
[6] Have never used tadalafil 5 mg or 2.5 mg once a day therapy.
[7] Anticipate having the same adult female sexual partner during the study. (If a qualifying participant has more than one female partner during the study the participant will not be excluded from the trial, however the participant will be required to respond to questionnaires based on his sexual interactions with only one of these partners.)
[8] Agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication. (Subjects who do not make at least four sexual attempts during the run-in period will not be enrolled in the study; these subjects will be considered screen failures.)
[9] Agree not to use any other ED treatment, including herbal therapy, during the run-in period, the open-label treatment phase of the study, and for 96 hours after the final study visit is completed.
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) yes
F.1.3.1 Number of subjects for this age range
[10] Present with impotence caused by other primary sexual disorders including premature ejaculation or impotence caused by untreated endocrine disease (for example, hypopituitarism, hypothyroidism, or hypogonadism).
[11] Have a history of radical prostatectomy, or other pelvic surgery with subsequent failure to achieve erection.
[12] Have a history of penile implant.
[13] Have a clinically significant penile deformity (such as Peyronie’s disease) in the opinion of the investigator.
[14] Exhibit evidence of clinically significant renal insufficiency as determined by the investigator.
[15] Exhibit evidence of active symptomatic hepatobiliary disease, as determined by the investigator.
[16] Exhibit Hemoglobin A1c >11% at Visit 1, in subjects with a history of diabetes mellitus of any type.
[17] Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months.
[18] Have met the criteria for unstable angina (Protocol Attachment S024.3) within 6 months before Visit 1, or have a history of myocardial infarction or coronary artery bypass graft surgery within 90 days before Visit 1, or percutaneous coronary intervention (for example, angioplasty or stent placement) within 90 days before Visit 1.
[19] Have any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 bpm) at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for =30 sec) despite medical or device therapy, or use an internal cardioverter-defibrillator.
[20] Have a history of sudden cardiac arrest despite medical or device therapy.
[21] Exhibit any evidence of congestive heart failure (NYHA Class 2 or above, Protocol Attachment S024.4) within 6 months before Visit 1.
[22] Have had a new or significant conduction defect within 90 days before Visit 1.
[23] Exhibit systolic blood pressure >170 or <90 mmHg or diastolic blood pressure >100 or <50 mmHg at screening (if stress is suspected, retest under basal conditions), or have a history of malignant hypertension.
[24] Have a history of significant central nervous system injuries (including stroke and spinal cord injury) within the last 6 months.
[25] Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
[26] Have retinitis pigmentosa.
[27] Have a history of human immunodeficiency virus (HIV) infection.
[28] Have a condition that in the opinion of the investigator would interfere with the subject’s ability to provide informed consent or comply with study instructions, would place the subject at increased risk, or might confound the interpretation of study results.
[29] Currently receive treatment with nitrates, nonselective alpha [1]-adrenergic blockers (such as doxazosin), cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia™ or Proscar® or Avodart® [dutasteride]).
[30] Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
[31] Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance.
[32] Are investigator site personnel directly affiliated with this study and/or their immed
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