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Study on the Safety and Effectiveness of LIB-01 for Treating Erectile Dysfunction in Adult Men

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of erectile dysfunction (ED), a condition where a man has difficulty achieving or maintaining an erection. The treatment being tested is called LIB-01 MONOHYDRATE, which is a powder that is mixed with liquid to create an oral suspension. This means it is taken by mouth. The trial will also include a placebo group to compare the effects of the treatment.

The purpose of the study is to evaluate how effective and safe LIB-01 is for treating erectile dysfunction. Participants in the study will be randomly assigned to receive either the treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will last for a period of up to three weeks, during which participants will take the treatment or placebo and attend regular check-ups to monitor their progress and any side effects.

Throughout the study, participants will be asked to complete questionnaires about their erectile function and overall satisfaction. The main goal is to see if there is an improvement in erectile function after taking LIB-01 compared to the placebo. Safety will also be closely monitored by checking for any adverse effects, changes in vital signs, and other health indicators. The study aims to provide valuable information on whether LIB-01 can be a safe and effective treatment option for men with erectile dysfunction.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be asked to provide signed and dated written informed consent. This confirms your understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    You will undergo an initial assessment to ensure you meet the eligibility criteria. This includes being a male aged 25 to 65 years, in a stable heterosexual relationship for at least 6 months, and having a specific score on the erectile function questionnaire.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either the study medication, LIB-01 monohydrate, or a placebo. The medication is in the form of a powder for oral suspension, which you will take by mouth.

    The dosage and frequency of the medication will be provided by the study team, and you will be required to follow these instructions carefully throughout the trial.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, your health and response to the medication will be monitored. This includes regular check-ups and completing questionnaires about your erectile function and overall satisfaction.

    You will be asked to report any side effects or changes in your health to the study team immediately.

  5. Step 5

    End of trial assessment

    At the end of the trial, you will undergo a final assessment to evaluate the effects of the medication. This includes a review of your questionnaire responses and any changes in your health.

    You will also be asked to refrain from donating sperm for 3 months after the last dose of the medication.

Who can join the trial?

7 criteria

  • Provide signed and dated written informed consent before any trial-specific procedures. This means you agree to participate after understanding the study details.
  • Be a male participant aged between 25 and 65 years at the screening visit.
  • Be in a stable heterosexual relationship for at least 6 months before the screening visit.
  • Have a total score of 11-25 on specific questions of the IIEF questionnaire, which assesses erectile function.
  • Be highly motivated to obtain treatment for erectile dysfunction (ED).
  • Be willing to abstain from unprotected sex or use a condom to prevent drug exposure to a partner from the first dose of the study medication to 24 hours after the last dose. Also, refrain from donating sperm from the date of dosing until 3 months after the last dose. If you have a female partner who can become pregnant, she must use highly effective contraceptive methods until the end of the trial.
  • Understand the trial requirements.

Who cannot join the trial?

3 criteria

  • Patients who are female cannot participate in the study.
  • Patients who are not within the specified age range cannot participate. The study is for adult males only.
  • Patients who are part of a vulnerable population cannot participate. This means groups that might need special protection or care.
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Investigated drugs

LIB-01 is a medication being tested in this clinical trial to see if it can help treat erectile dysfunction, which is a condition where a man has difficulty getting or keeping an erection. The trial aims to find out if LIB-01 is effective in improving this condition and also to ensure that it is safe for use. Participants in the trial will receive LIB-01 to see how well it works and to monitor any side effects they might experience.

What is already known about the treatment

LIB-01 – LIB-01 is a medication currently being studied in a clinical trial for its potential to treat erectile dysfunction (ED). It is administered in a form that is not specified in the trial data, but it is likely taken orally or applied topically, as these are common methods for ED treatments. The trial is in Phase 2a, which means researchers are testing its effectiveness and safety in a small group of people. The main goal is to see if LIB-01 can help improve erectile function. While the exact mechanism of action at the molecular level is not detailed, medications for ED typically work by increasing blood flow to the penis. LIB-01 is classified under pharmacological treatments for erectile dysfunction.

Investigated diseases

Erectile dysfunction – Erectile dysfunction is a condition where a man has difficulty achieving or maintaining an erection sufficient for sexual intercourse. It can result from problems with blood flow, nerve supply, or hormones. The condition may develop gradually, with increasing difficulty in achieving erections over time. Psychological factors such as stress, anxiety, or depression can also contribute to its progression. Erectile dysfunction can affect a man's self-esteem and relationships. It is a common condition, especially in older men, but can occur at any age.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515065-34-00Protocol codeDCT4564Estimated enrolment140 patientsSponsorDicot AB

sourced from the EU Clinical Trials Register and site verification

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