A First in Human Study, Evaluating the Safety and Efficacy of ADAM™ 1.0

Launched by CONTRALINE, INC · Nov 13, 2021

Keywords

ClinConnect Summary

This clinical trial is testing a new system called the ADAM™ 1.0, designed for male contraception. The study aims to assess how safe and effective this system is when implanted into a part of the male reproductive system called the vas deferens, which is responsible for transporting sperm. The trial will include 25 healthy men aged between 25 and 65 years who have normal sperm counts and are willing to participate in follow-up visits and provide semen samples during the study.

To be eligible for this trial, men must be in good health and not have any significant medical issues that could interfere with the study. They should also agree to use another form of contraception during the trial to prevent pregnancy. Participants will receive detailed information about the study and must provide written consent before joining. It’s important to know that this is an early-stage study, so the risks and benefits of the ADAM™ system are still being evaluated. The trial is currently active but not recruiting new participants.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. The subject is male
• • 2. Subject is 25 to 65 years of age
• • 3. Subject has a normal semen analysis (≥ 15 million sperm/mL, ≥40% total motility) defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
• • 4. Subject is suitable to undergo a vasectomy as a long-term form of contraception
• • 5. Subject is legally competent
• • 6. In the opinion of the Investigator, the subject is willing and able to comply with the protocol, return for all follow-up visits and complete all protocol assessments, which includes providing recurring semen samples
• • 7. Subject agrees to use an alternative method of contraception with any female partner of reproductive age during the course of the study treatment until study exit occurs
• • 8. Subject is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study.
• • 9. The subject has been informed of the nature of the study, agrees to its provisions, and has willingly provided written informed consent, approved by the appropriate Human Research Ethics Committee (HREC)
• Exclusion Criteria:
• * Potential subjects will be excluded if ANY of the following criteria apply:
• • 1. Subject is participating in another interventional clinical trial currently or within the past 3 months from the time of screening
• • 2. Subject has history of prior hormonal therapy use (e.g., androgenic steroids, GnRH agonists and antagonists) within the past 6 months
• • 3. Subject on exam has any of the following: vas not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study
• • 4. Subject has allergic reaction to polyethylene glycol (PEG) containing products or has had a prior severe allergic response to injectable or implantable devices
• • 5. Subject has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be admitted after resolution of an acute infection
• • 6. Subject has current coagulopathy or other bleeding disorders
• • 7. Subject currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy, alpha blocker)
• • 8. Subject had a previous successful or unsuccessful vasectomy or vasectomy reversal
• • 9. Subject has any clinically significant abnormal findings or other findings identified by Investigator that would exclude the subject.