BridgeMD
A Phase 2a, Randomised, Double-blind, Parallel and Placebo-controlled Trial Investigating Safety and Efficacy of LIB-01 in Treatment of Erectile Dysfunction
EU CTIS ID: 2024-515065-34-00
What this study is testing
To evaluate the efficacy of LIB-01 in the treatment of erectile dysfunction (ED). Safety objective: To evaluate the safety of LIB-01.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provision of signed and dated written informed consent prior to any trial specific procedures.
- Male participant aged 25 to 65 years, inclusive, at the screening visit.
- In a stable heterosexual relationship for at least 6 months prior to the screening visit.
- Total score of 11-25 on questions 1-5 and 15 on the EF domain of the IIEF questionnaire.
- Highly motivated to obtain treatment for ED.
- Willing to abstain from unprotected sex, or willing to use condom to prevent drug exposure of a partner from first dose of IMP to 24 hours after the last dose. In addition, refrain from donating sperm from the date of dosing until 3 months after (last) dosing with the IMP. Any female partner of child-bearing potential of a non-vasectomised trial participant must use contraceptive methods with a failure rate of < 1% to prevent pregnancy until the end-of-trial visit. Participants in the Netherlands: Willing to abstain from unprotected sex and use condom to prevent drug exposure of a partner and pregnancy from first dose until the end-of-trial. In addition, refrain from donating sperm from the date of dosing until 3 months after (last) dosing with the IMP. Any female partner of child-bearing potential of a non-vasectomised trial participant must use contraceptive methods with a failure rate of < 1% to prevent pregnancy until the end-of-trial visit.
You likely can't join if
- History of any clinically significant disease or disorder, including psychiatric disorder, which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant’s ability to participate in the trial.
- History of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION).
- History of prostatectomy.
- History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator.
- History of, or current use of anabolic steroids, as judged by the Investigator.
See the full eligibility criteria
Who can join
- Provision of signed and dated written informed consent prior to any trial specific procedures.
- Male participant aged 25 to 65 years, inclusive, at the screening visit.
- In a stable heterosexual relationship for at least 6 months prior to the screening visit.
- Total score of 11-25 on questions 1-5 and 15 on the EF domain of the IIEF questionnaire.
- Highly motivated to obtain treatment for ED.
- Willing to abstain from unprotected sex, or willing to use condom to prevent drug exposure of a partner from first dose of IMP to 24 hours after the last dose. In addition, refrain from donating sperm from the date of dosing until 3 months after (last) dosing with the IMP. Any female partner of child-bearing potential of a non-vasectomised trial participant must use contraceptive methods with a failure rate of < 1% to prevent pregnancy until the end-of-trial visit. Participants in the Netherlands: Willing to abstain from unprotected sex and use condom to prevent drug exposure of a partner and pregnancy from first dose until the end-of-trial. In addition, refrain from donating sperm from the date of dosing until 3 months after (last) dosing with the IMP. Any female partner of child-bearing potential of a non-vasectomised trial participant must use contraceptive methods with a failure rate of < 1% to prevent pregnancy until the end-of-trial visit.
- Understands the trial requirements.
What rules you out
- History of any clinically significant disease or disorder, including psychiatric disorder, which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant’s ability to participate in the trial.
- History of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION).
- History of prostatectomy.
- History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator.
- History of, or current use of anabolic steroids, as judged by the Investigator.
- Bleeding deficiencies or ongoing anticoagulant therapy that would put the participant at risk, as judged by the investigator.
- Uncontrolled cardiac disease within 6 months of screening, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction or cerebrovascular accident.
- Use of nitrate medications within 14 days prior to the screening visit.
- Use of any drug with narrow therapeutic index or drugs that are sensitive substrates, strong inducers or strong inhibitors to CYP3A4 as well as substrates and inhibitors of OATP1B1 or sensitive to substrates to CYP2B6 in accordance with the list provided (see Section 9.6.2.1).
- Use of oral, injectable, intra-urethral, or topical pro-erectile drugs or supplements, including but not limited to PDE5-Is or prostaglandin E1, or use of devices for ED treatment, within 14 days prior to screening.
- Type 1 diabetes.
- Primary hypoactive sexual desire.
- Presence of penile anatomical abnormalities, such as penile fibrosis or Peyronie’s disease, which would cause significantly impaired sexual performance, as judged by the Investigator.
- Insufficient therapeutic effect when using PDE5-Is.
- History of, or ongoing antiandrogen treatment.
- Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B and C antibodies and/or human immunodeficiency virus (HIV).
- Abnormal vital signs, laboratory test value or ECG of clinical significance, as judged by the Investigator.
- Moderate to severe renal impairment with an eGFR (creatinine) ≤60 mL/min (revised Malmö-Lund equation).
- Moderate to severe hepatic impairment at the time of the screening visit, as judged by the Investigator.
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the last three months prior to the screening visit.
- Planned treatment or treatment with another investigational therapy (i.e., small molecule or biologic) within 3 months prior to the screening visit.
- Haemoglobin A1c (HbA1c) ≥48 mmol/L (6.5%).
- Involvement in the planning, and/or conduct of the trial.
- The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to LIB-01 API.
- History of priapism, or increased risk due to underlying illness, including but not limited to hemoglobinopathies such as sickle cell anaemia or thalassemia.
- History of glaucoma.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.