Ongoing Clinical Trials for Erectile Dysfunction
Currently, there are 4 ongoing clinical trials investigating new treatments for erectile dysfunction. These studies are testing different approaches, including botulinum toxin injections, hormone therapy combined with standard medications, platelet-rich plasma with shockwave therapy, and a novel oral medication. Trials are taking place in Spain, Denmark, Sweden, and the Netherlands, offering opportunities for men who have not responded well to conventional treatments.
Clinical trial locations
- Denmark
- Netherlands
- Spain
- Study of Botulinum Toxin and Saline Solution for Erectile Dysfunction in Patients Unresponsive to Standard Treatments
- Study on Levothyroxine and Sildenafil for Improving Erectile Function in Patients with Subclinical Hypothyroidism and Erectile Dysfunction
- Study on the Effectiveness of Platelet Concentrate and Shockwave Therapy for Men with Mild to Moderate Erectile Dysfunction
- Sweden
Study of Botulinum Toxin and Saline Solution for Erectile Dysfunction in Patients Unresponsive to Standard Treatments
This trial is testing a novel approach using Onabotulinumtoxin A, commonly known as botulinum toxin, for men whose condition has not improved with standard treatments. The medication is injected directly into the corpora cavernosa, the sponge-like regions of the penis that fill with blood during an erection.
Who can participate: Men over 30 years old who have tried conventional treatments such as phosphodiesterase-5 inhibitors or injections like Caverject or Bimix/Trimix without sufficient success, measured by a score of 12 or less on the IIEF-15 questionnaire. Participants must be willing to attend follow-up appointments and undergo necessary tests throughout the study period.
Who cannot participate: The study excludes individuals who are not male, under 18 years of age, or part of vulnerable populations who cannot make decisions for themselves.
Treatment approach: The trial uses Onabotulinumtoxin A injections administered with sodium chloride solution directly into the penile tissue. The goal is to determine whether these injections can improve the firmness of erections in men who have not responded to other therapies. The medication works by blocking the release of certain neurotransmitters, helping to relax muscles and improve blood flow. The study is designed as a double-blind trial, meaning neither participants nor researchers will know who receives the actual medication versus placebo, ensuring unbiased results.
The trial is expected to conclude by September 2026, with regular monitoring throughout to assess improvements in erectile rigidity and overall sexual function.
Study on Levothyroxine and Sildenafil for Improving Erectile Function in Patients with Subclinical Hypothyroidism and Erectile Dysfunction
This trial explores the connection between thyroid function and erectile health by testing levothyroxine in men with both subclinical hypothyroidism and erectile dysfunction. Subclinical hypothyroidism occurs when the thyroid gland doesn’t produce quite enough hormones, though not severely enough to cause obvious symptoms.
Who can participate: Heterosexual men over 18 years who are sexually active and have been diagnosed with subclinical hypothyroidism, indicated by a thyroid-stimulating hormone level greater than 5 with normal T4 levels. They must also have erectile dysfunction confirmed by an IIEF-15 score of less than 25 points. Participants need to be able to complete several health questionnaires throughout the study.
Who cannot participate: Men without subclinical hypothyroidism or erectile dysfunction, those outside the specified age range, and individuals from vulnerable populations are excluded.
Treatment approach: Participants will be randomly assigned to receive levothyroxine, sildenafil, or placebo for three months. Levothyroxine is a thyroid hormone replacement that helps regulate various bodily functions, including sexual activity. The dosage is adjusted based on weight and baseline TSH levels. Sildenafil, commonly used for erectile dysfunction, serves as a comparison to see whether treating the underlying thyroid condition with levothyroxine can be as effective as standard erectile dysfunction medication. Both medications are taken orally in tablet form.
The study aims to provide insights into whether addressing thyroid hormone deficiency can improve erectile function, potentially offering a new treatment avenue for men with both conditions.
Study on the Effectiveness of Platelet Concentrate and Shockwave Therapy for Men with Mild to Moderate Erectile Dysfunction
This trial investigates a regenerative medicine approach combining platelet-rich plasma with focal shockwave therapy for men with mild to moderate erectile dysfunction.
Who can participate: Men over 18 years who have experienced erectile dysfunction in more than 50% of sexual activities for at least 3 months. They must have a baseline IIEF-EF score between 11 and 21 and be in a stable heterosexual relationship of at least 6 months. Participants must commit to having at least 3 sexual activities per month after treatment and agree not to use other erectile dysfunction treatments during the study and for 6 months afterward.
Who cannot participate: Men under 18, those with severe erectile dysfunction, and individuals from vulnerable populations are excluded.
Treatment approach: Platelet-rich plasma is prepared from the patient’s own blood and injected into the erectile tissue. This concentrate contains growth factors that may help repair and regenerate tissues, potentially improving blood flow and function. The treatment is combined with focal shockwave therapy, which uses sound waves to stimulate blood vessel growth and enhance circulation. The 12-week treatment is followed by assessments at weeks 13, 21, and 33 to measure improvements in erectile function, sexual quality of life, and overall satisfaction.
This regenerative approach represents a different strategy from traditional medications, aiming to address the underlying tissue and blood flow issues rather than providing temporary symptom relief.
Study on the Safety and Effectiveness of LIB-01 for Treating Erectile Dysfunction in Adult Men
This international trial is testing LIB-01 monohydrate, a new oral medication in powder form that is mixed with liquid before taking.
Who can participate: Men aged 25 to 65 years in a stable heterosexual relationship for at least 6 months. Participants must have an IIEF score between 11 and 25, indicating moderate erectile dysfunction, and be highly motivated to obtain treatment. They must agree to use contraception or condoms during the study and refrain from donating sperm for 3 months after the last dose. If their partner can become pregnant, she must use highly effective contraceptive methods throughout the trial.
Who cannot participate: Women, men outside the specified age range, and individuals from vulnerable populations cannot participate.
Treatment approach: LIB-01 is administered as an oral suspension taken by mouth. The study is double-blind, meaning neither participants nor researchers know who receives the actual medication versus placebo. The treatment period lasts up to three weeks, with regular check-ups to monitor progress and side effects. Participants complete questionnaires about erectile function and overall satisfaction to help researchers evaluate the medication’s effectiveness.
This Phase 2a trial aims to establish both the safety and effectiveness of LIB-01, medications for erectile dysfunction typically work by increasing blood flow to the penis, though the exact mechanism of this particular drug is still under investigation.
Summary
The four ongoing clinical trials represent diverse approaches to treating erectile dysfunction. Three of the four trials are taking place in Spain, suggesting a concentration of research activity in this country. The studies explore different mechanisms: botulinum toxin injections for treatment-resistant cases, thyroid hormone replacement for men with underlying hormone imbalances, regenerative medicine using the body’s own platelets combined with shockwave therapy, and a novel oral medication.
Most trials focus on men who have not responded well to standard treatments or have mild to moderate condition severity. The studies generally require participants to be in stable relationships and willing to commit to follow-up assessments over several weeks or months. All trials include placebo groups to ensure accurate assessment of treatment effectiveness.
The international LIB-01 study, spanning Denmark, Sweden, and the Netherlands, is the only multi-country trial, while Spain hosts three different studies examining distinct treatment approaches. These trials offer hope for men seeking alternatives to conventional phosphodiesterase-5 inhibitors, particularly those with specific underlying conditions or treatment-resistant cases.
