ADAM 2.0
Are You Eligible?This study aims to evaluate, ADAM 2.0, a new medical device that works as a form of male contraception.
Research Objectives
Status
Recruitment
Total participants required
Study location
Study type
Patient group
About this clinical trial
This first in-human study aims to evaluate ADAM™ 2.0, a new male contraceptive device implanted into the vas deferens (tubes which sperms travel through) by a doctor. Unlike a vasectomy, which is usually permanent and requires complex surgery to reverse, ADAM™ 2.0 may allow sperm flow to return naturally over time. Made from safe, non-toxic materials used in other surgeries, ADAM™ 2.0 is expected to be low risk, similar to a vasectomy. This study will recruit 30 participants across 3 study sites within Australia. All participants will also be followed for up to two years to monitor sperm levels and implant dissolution by the body, with an offer of a vasectomy at no-cost (if applicable). ADAM™ 2.0 does not protect against STIs and is not yet proven to prevent pregnancy, so other birth control methods must be used during the study.
Trial Registration information – https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=388668
Eligibility
- Male adults aged 25 to 55 years of age (inclusive)
- Possess a healthy sperm count and motility based on semen tests conducted.
- Seek to undergo a vasectomy as a long-term form of contraception
- Must use alternative forms of contraception with any female partner during the study duration
Lead investigator
- Professor Eric Chung
Clinical trial coordinator
- Chris Henderson
Technical title
Open-label, Multi-Centre, First-in-Human Study to Assess the Safety, Efficacy and Feasibility of Implanting ADAM™ 2.0 in Fertile Males Who Are Suitable for a Vasectomy
This clinical trial is closed for recruitment
If you would like more information about this clinical trial, please complete the contact form below.