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Erectile DysfunctionPhase 2MENOXNCT05196308

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

A Phase 2 study testing Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH) in people with Erectile Dysfunction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
226 participants
Where
1 siteFrance
Study dates
18 Mar 2022to 15 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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.
Show all 29Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Neuro-Urology-Andrology, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP

    Garches, 92380

Other trials in France

About this study

Official title: Efficacy of Intracavernosal (Xeomin®) 100U 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

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:

Read more
  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.
  1. to assess effect persistence at month 6 and month 9.
  2. to assess safety of (Xeomin®) 100U IC in combination with sildenafil 100 mg on demand.
Read the detailed 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.

Being tested
Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH), Placebo administration
Keywords
Erectile Dysfunction, phosphodiesterase type 5 inhibitors, efficacy
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH)Drug

    Administration of the investigational product.

    For the double-blind treatment phase, experimental group :

    Patients will receive Xeomin® (MERZ PHARMACEUTICALS GMBH), 100 U, a paired intracavernosal injection to be performed by the investigator.

  • Placebo administrationDrug

    For the double-blind treatment phase, control group :

    Patients will receive placebo of Xeomin® 100 U, a paired intracavernosal injection is to be performed by the investigator.

Study groups in NCT05196308
Study groupRoleWhat they receive
Xeomin® receiversExperimentalPatients will receive Xeomin®.
Receives: Drug: Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH)
Placebo receiversPlacebo comparatorPatients will receive placebo injection instead of Xeomin®.
Receives: Drug: Placebo administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the erectile function

    Change in the erectile function between baseline and month 3, measured by the International Index of Erectile Function - Erectile Function domain score (IIEF-EF).

    The International Index of Erectile Function (IIEF) is a 15-item self-report instrument assessing male sexual function. The Erectile Function (EF) domain score of the IIEF, comprised of items 1 to 5 and 15 from the IIEF, is used in this study.

    Measured: at baseline and month 3

  2. Change in SEP2

    Question providing information as whether the erection is hard enough to penetrate (SEP2).

    The SEP is a log diary with 5 questions answered after each sexual intercourse attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3) or a satisfactory sexual experience (SEP 4).

    Measured: at baseline and month 3

  3. Change in SEP3

    Question providing information as duration of erectile.

    The SEP is a log diary with 5 questions answered after each sexual intercourse attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3) or a satisfactory sexual experience (SEP 4).

    Measured: at baseline and month 3

Secondary outcomes (4)

  1. Change in SEP 4 score

    Percentage of SEP 4 of the Sexual Encounter Profile questionnaire

    The SEP is a log diary with 5 questions answered after each sexual intercourse attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3) or a satisfactory sexual experience (SEP 4).

    Measured: at baseline and month 3

  2. The Erection Hardness Score (EHS)

    Change in the mean Erection Hardness Score at 3-, month (±2 weeks) after placebo or Xeomin® 100U IC injection compared to baseline. (Mulhall JP et al. Validation of the erection hardness score. J Sex Med. 2007;4(6):1626-1634). The EHS is a single-item Likert scale. The tool asks men to consider the question 'How would you rate the hardness of your erection?' and select one of the options below:

    0 - Penis does not enlarge; 1 - Penis is larger, but not hard; 2 - Penis is hard, but not hard enough for penetration; 3 - Penis is hard enough for penetration, but not completely hard; 4 - Penis is completely hard and fully rigid.

    Measured: at baseline and month 3

  3. Global Assessment Question (GAQ)

    "Has the treatment you have been taking over the past 4 weeks improved your erections? (Please compare your current erections after treatment with your erections before your participation in this study)": yes or no: Change in the percentage of "yes" answer at 3-month (±2 weeks) after placebo or Xeomin® 100U IC injection compared with baseline.

    Measured: at baseline and month 3

  4. Persistence of efficacy

    Persistence of efficacy at 6- and 9- month post-treatment administration using the same tools (IIEF-EF, SEP, EHS, GAQ) among patients for whom treatment has been assessed as efficient individually.

    Individual efficacy of treatment in each patient will be assessed using minimally clinically important difference (MCID) for the IIEF-EF domain according to ED severity (Rosen 2011) i. e. MCID ≥ 5 for moderate ED (IIEF-EF 11-16) and MCID ≥ 7 for severe ED (IIEF-EF6-10).

    Measured: at 6- and 9- month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2022
  2. Study start18 Mar 2022
  3. Primary completion23 Jul 2024
  4. Study completion15 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05196308
Sponsor's protocol ID
APHP211042
Other IDs
2021-005496-39
Acronym
MENOX
Status last verified
Nov 2024
First submitted
5 Jan 2022
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fisher WA, Gruenwald I, Jannini EA, Lev-Sagie A, Lowenstein L, Pyke RE, Reisman Y, Revicki DA, Rubio-Aurioles E. Standards for Clinical Trials in Male and Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual Dysfunction. J Sex Med. 2017 Jan;14(1):3-18. doi: 10.1016/j.jsxm.2016.08.016.

    PubMed 28065358

  • Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K. Validation of the erection hardness score. J Sex Med. 2007 Nov;4(6):1626-34. doi: 10.1111/j.1743-6109.2007.00600.x. Epub 2007 Sep 21.

    PubMed 17888069

  • Giuliano F, Denormandie AC, Madec FX, Carnicelli D, Graziana JP, Droupy S, Marcelli F, Gassama M, Grimaldi L; MENOX study group. Efficacy and safety of intracavernosal incobotulinumtoxinA (Xeomin) as add-on therapy to sildenafil for the treatment of erectile dysfunction insufficiently responsive to phosphodiesterase type 5 inhibitors. J Sex Med. 2025 Nov 2;22(11):1994-2001. doi: 10.1093/jsxmed/qdaf225.

    PubMed 40971935

  • Giuliano F, Denys P, Joussain C. Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin(R)) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series. Toxins (Basel). 2022 Apr 16;14(4):286. doi: 10.3390/toxins14040286.

    PubMed 35448895

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Investigational product administration Xeomin® (MERZ PHARMACEUTICALS GMBH) in people with Erectile Dysfunction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the erectile function (time frame: at baseline and month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05196308, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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