Efficacy of Intracavernosal as add-on Therapy to Sildenafil 100 mg on Demand Compared to Sildenafil 100 mg on Demand for the Treatment of Erectile Dysfunction (ED) Not Sufficiently Responsive to Standard Therapy With Phosphodiesterase Type 5 Inhibitors (MENOX)

  • STATUS
    Recruiting
  • End date
    Mar 26, 2024
  • participants needed
    226
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 26 April 2022
sildenafil
sham treatment
pde-5 inhibitors

Summary

The primary objective of this study is to investigate the efficacy of intracavernosal (Xeomin®) (100U) as add-on therapy to sildenafil 100 mg on demand in men with ED and insufficient response to standard therapy with 100 mg sildenafil on demand during the 4-week open-label run-in phase.

The secondary objectives are to further describe the efficacy and safety of (Xeomin®) 100U IC as add-on therapy to sildenafil 100 mg on demand:

  1. to further assess efficacy using.
    • i) a log diary five-item questionnaire completed after each sexual attempt (Sexual Encounter Profile);
    • ii) a self-reporting measure that scores erection hardness on a 4 point scale completed after each sexual attempt;
    • iii) The Global Assessment Question.
  2. to assess effect persistence at month 6 and month 9.
  3. to assess safety of (Xeomin®) 100U IC in combination with sildenafil 100 mg on demand.

Description

This randomized, double-blind, placebo-controlled study will be conducted in 9 centers, study participants will be adult men with ED and insufficient response to standard therapy with 100 mg sildenafil on demand during the 4-week open label run-in-phase, follow-up in the study will be 10±2 months.

This is a standard procedure to use placebo as control in studies assessing the efficacy of pharmacological treatment of ED. Furthermore the placebo group provides a benchmark for an objective analysis of safety and tolerability findings. The open-label run-in phase assures that only subjects who are true non-responders i.e. with insufficient response to standard therapy with 100 mg sildenafil prn during the 4-week open-label run-in phase are randomized and participate in the double-blind treatment phase.

Participants distributed between groups at a ratio of 1:1.

Details
Condition Erectile Dysfunction
Treatment Placebo Administration, Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH)
Clinical Study IdentifierNCT05196308
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects have to fulfill all of the following criteria before being included in the
open-label run-in phase
Written informed consent obtained from the subject
History of ED for at least 6 months prior to screening, defined as "the inability to
achieve and maintain an erection of the penis sufficient to complete satisfactory
sexual intercourse" (NIH), the diagnosis of ED has to be confirmed by a physician
Understanding of study procedures and willingness to abide by all procedures during
the course of the study
Male subject aged ≥18 to ≤ 80 years at visit 1
Have a monogamous relationship with a female sexual partner (vaginal penetration
required for several of the primary efficacy variables) for at least 6 months prior to
screening
Highly motivated to obtain treatment for ED
History of previous use of at least 1 marketed PDE5 inhibitor and insufficient
therapeutic efficacy despite use of the highest approved dose
Subjects have to fulfill all of the following criteria before being included in the double
blind treatment phase
At least 4 attempts at sexual intercourse during the open-label run-in phase with use
of 100 mg sildenafil approximately 1 hour before attempting intercourse
IIEF-EF score <17
At least 50% of attempts at sexual intercourse during the open-label run-in phase had
been unsuccessful i.e. the following question in the Subject Diary had to be answered
with "No
Did your erection last long enough for you to have successful intercourse?" (SEP3: success
in maintenance of erection)
Highly motivated to obtain treatment for ED according to the investigator judgment
Ability to understand and follow study-related instructions

Exclusion Criteria

Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or
to any of the excipients (Human albumin, sucrose)
BW <50 kg
ED caused by other primary sexual disorders including premature ejaculation or ED
caused by untreated endocrine disease (eg, hypopituitarism, hypothyroidism, or
hypogonadism)
History of penile implant
The presence of clinically significant penile deformity in the opinion of the
investigator
Patients with chronic stable angina treated with long-acting nitrates, or patients
with chronic stable angina who have required short-acting nitrates in the last 90
days, or angina occurring during sexual intercourse in the last 6 months
Patients having met the criteria for unstable angina within 6 months prior to Visit 1
history of myocardial infarction or coronary artery bypass graft surgery within 90
days prior to Visit 1, or percutaneous coronary intervention (eg, angioplasty or stent
placement) within 90 days prior to Visit 1
Any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart
rate >100 bpm) at rest despite medical or device therapy, or any history of
spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for 30
sec) despite medical or device therapy, or the presence of an automatic internal
cardioverter-defibrillator
A history of sudden cardiac death (arrest) despite medical or device therapy
Any evidence of congestive heart failure within 6 months prior to Visit 1
A significant conduction defect within 90 days prior to Visit 1
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 patients
with malignant hypertension
<12 weeks since most recent injection of BTX-A/B into any body region for any
indication
Neurological disorder associated with neuro muscular dysfunction of any kind in
medical history
Planned concomitant treatment with BTX -A/B of any body region during the study
Known hypersensitivity to human serum albumin, sucrose, or the active substance BTX-A
Generalized disorders of muscles activity (e.g. myasthenia gravis
Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis) or any other significant
peripheral neuromuscular dysfunction which might interfere with the study
Any condition that would interfere with the patient's ability to provide informed
consent or comply with study instructions, would place patient at increased risk, or
might confound the interpretation of the study results
Current treatment with nitrates (as outlined in previous Exclusion Criterion, cancer
chemotherapy, or anti-androgens
History of drug, alcohol, or substance abuse within the past 6 months
Investigators, site personnel directly affiliated with this study, and their immediate
families. Immediate family is defined as a spouse, parent, child or sibling, whether
biological or legally adopted
Treatment within the last 30 days with a drug or device that has not received
regulatory approval at the time of study entry
Ongoing severe or uncontrolled systemic disease, current malignancy, haemophilia, or
HIV infection in medical history
Severe or uncontrolled respiratory disease in medical history
Evidence or suspicion that the subject is not willing or unable (e.g.due to severe
cognitive communication impairment) to understand the information that is given to him
as part of the informed consent, in particular regarding the risks and discomfort
which he would agree to be exposed to
Any reason which in the investigator's opinion is likely to compromise the subject's
ability to participate in the study
Subject who is imprisoned or is lawfully kept in an institution
Participation in a clinical study within 12 weeks prior to screening or planned
participation during this study
Previous participation in this clinical study
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