Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life - LVGH

Phase 1

• Conditions: Erectile Dysfunction; MedDRA version: 8.1Level: LLTClassification code 10061461Term: Erectile dysfunction

• Registration Number: EUCTR2006-002922-51-FR
• Lead Sponsor: illy ICOS LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-09
• Study Completion: 2008-01-03
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 320

Inclusion Criteria

Subject Inclusion Criteria:
[1] Are male and at least 18 years of age at Visit 1.
[2] Are able to read, understand and provide signed informed consent.
[3] Have a history of erectile dysfunction (ED: defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
[4] Anticipate having the same adult female sexual partner during the study who is willing to participate in recording responses to efficacy questionnaires, sexual quality of life questionnaires, and other instruments used in this study.
[5] Agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in phase without medication.
[6] Agree not to use any other ED treatment, including herbal therapy, during the 4-week run-in phase before being randomized to therapy for the double-blind treatment phase of the study, and for 96 hours after the final study visit.

Partner Inclusion Criteria:
[8] Are female and at least 18 years of age at Visit 1 and who will have the same male study subject as her sexual partner during the study.
[9] Able to read, understand and provide signed informed consent.
[10] Agree to make at least four sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase without medication.
[11] Adequate sexual function not consistent with sexual dysfunction as determined by a FSFI total score > 26.55
[12] Motivated to support the male partner’s treatment for ED as demonstrated by a score of at least 2 on the following commitment items:
•Item A; How important is sexual activity to you?
•Item B; Overall, how important is it for you to maintain or improve sexual activity with your partner?
[13] Willing to participate in recording responses to efficacy questionnaires, sexual quality of life questionnaires, and other instruments used in this study

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

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the following criteria:
[14] Previous or current treatment with tadalafil.
[15] Present with ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated or inadequately treated endocrine disease (for example, hypopituitarism, hypogonadism, or uncorrected hypothyroidism,). The subject may be included if, in the opinion of the investigator, the ED persists after adequate treatment of the underlying endocrine disease.
[16] Have a sexual partner that is not willing to complete the scales.
[17] Have a history of radical prostatectomy, or other pelvic surgery with subsequent failure to achieve any erection.
[18] Have a history of penile implant.
[19] Have a clinically significant penile deformity in the opinion of the investigator.
[20] Exhibit evidence of clinically significant renal insufficiency as determined by the investigator.
[21] Exhibit evidence of clinically significant hepatobiliary disease as determined by the investigator.
[22] Exhibit Hemoglobin A1c >13% at Visit 1.
[23] 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.
[24] Have met the criteria for unstable angina (Attachment LVGH.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.
[25] 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), or use an automatic internal cardioverter-defibrillator.
[26] Have a history of sudden cardiac arrest.
[27] Exhibit any evidence of congestive heart failure (NYHA Class 2 or above, Attachment LVGH.4) within 6 months before Visit 1.
[28] Have had a new, significant cardiac conduction defect within 90 days before Visit 1.
[29] Exhibit systolic blood pressure >170 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at screening (if stress is suspected, retest under basal conditions), or have history of malignant hypertension.
[30] Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
[31] Have a history of Human Immunodeficiency Virus (HIV) infection.
[32] Have any 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 subject at increased risk, or might confound the interpretation of the study results.
[33] Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens [except finasteride taken as Propecia or Proscar, or Avodart (dutasteride)].
[34] Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
[35] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[36] Are employed by Lilly or ICOS (that is, employees

Study & Design

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