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Trial registered on ANZCTR
Registration number
ACTRN12624001459516
Ethics application status
Approved
Date submitted
12/11/2024
Date registered
16/12/2024
Date last updated
19/06/2025
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
This is the first study in humans to test the safety, effectiveness, and practicality of ADAM™ 2.0, a biocompatible contraceptive implant. This implant is designed to be tested in men with normal fertility levels who are considering a vasectomy as a contraceptive option.
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Scientific 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.
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Secondary ID [1]
313244
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ADM-014
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Male Contraception
335561
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Condition category
Condition code
Reproductive Health and Childbirth
332132
332132
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0
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Contraception
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
ADAM™ 2.0 is a male contraceptive device designed to block sperm flow through the vas deferens as an alternative non-hormonal, non-permanent option to a traditional vasectomy. The intervention involves the implantation of a pre-formed hydrogel implant into the vas deferens. Delivered via a minimally invasive 15-30 minute procedure, similar to a non-scalpel vasectomy, performed by a urological surgeon with 10+ years of experience. All participating surgeons will receive 2 hours of hands-on device training 1 week prior to their first procedures, surgeons will be trained by Contraline’s chief medical officer and chief technology officer. The procedure can be carried out under local or general anaesthesia, depending on surgeon decision, and will be performed in a hospital environment with the entire procedure visit taking approximately 5 hours. Participants will have in-person visits with the investigator (30 minutes each) at screening, 14 days, 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months, as well as telephone visits with the study coordinator (10 minutes) at 7 days, 60 days, 4 months, 5 months, 7 months, 8 months, 9 months, 10 months, 11 month, 15 months and 21 months to monitor safety, effectiveness, and any potential complications. The intervention is standardized across participants. All visits will be used to assess the device's placement, monitor for side effects, and gather data on its long-term efficacy, with adherence to the protocol closely monitored through regular follow-ups and participant questionnaires.
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Intervention code [1]
329824
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Treatment: Devices
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Safety of ADAM™ 2.0
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Assessment method [1]
339709
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Safety will be assessed by the number of percentage of treatment-emergent adverse events related to the device and/or procedure. Treatment-emergent adverse events, such as scrotal swelling, scrotal bruising and scrotal pain will be self-reported using an ePRO that will allow the participants to report any new adverse events.
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Timepoint [1]
339709
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7 days, 14 days, 30 days, 60 days, 90 days, 6 months, 9 months, 12 months, 18 months and 24 months post implantation procedure.
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Secondary outcome [1]
440965
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Efficacy of ADAM 2.0
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Assessment method [1]
440965
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Efficacy will be assessed by recording the number and percentage of participants who achieve 100,000 non-motile sperm/mL (azoospermia), 250,000 sperm/mL, 1 million sperm/mL and 3 million sperm/mL through laboratory semen analysis.
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Timepoint [1]
440965
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Day 7, Day 14, Day 30, Day 60. Day 90, 6 month, 9 month, 12 month, 18 month and 24 months after implantation.
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Secondary outcome [2]
440967
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Feasibility of implanting ADAM 2.0
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Assessment method [2]
440967
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Procedural success, defined as intraluminal delivery of ADAM 2.0 into the lumen of each vas deferens, confirmed through visual inspection.
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Timepoint [2]
440967
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During implantation procedure.
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Eligibility
Key inclusion criteria
Potential participants must meet ALL the following criteria to be eligible for enrolment into the study:
1. Participant is male.
2. Participant is 25 to 55 years of age (at the time of consent).
3. Participant’s semen analysis meets the requirements from the World Health Organization (WHO) 6th Edition Laboratory Manual for the Examination and Processing of Human Semen):
a. Semen volume =1.4 mL
b. Sperm concentration =16 million/mL
c. Total sperm number =39 million/ejaculate
d. Progressive motility =30%
e. Total motility =42%
f. Normal morphology =4%
g. Vitality =54% live spermatozoa
h. pH =7.2
Results are to be evaluated from 2 semen samples collected during the screening period, with each sample collected after =2 days and =7 days of refraining from ejaculation. The second sample must be collected within 10 days of the first sample, observing the required period of refraining from ejaculation. Both timing requirements (refraining from ejaculation and interval between samples) must be met for the participant to qualify for enrolment. Participants will not be permitted to repeat the screening semen analysis if the sample timing requirements are not met.
4. Participant is seeking and suitable to undergo a vasectomy as a long-term form of contraception.
5. Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures.
6. In the opinion of the investigator, the participant 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. Participant agrees to use an alternative method of contraception with any female partner of childbearing potential during the course of the study until study exit occurs.
8. Participant is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study.
9. The participant has been informed of the nature of the study, agrees to its provisions, and has willingly provided written informed consent.
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Minimum age
25
Years
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Maximum age
55
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Potential participants will be excluded if ANY of the following criteria apply:
1. Participants who have previously participated in a trial involving ADAM™ or are currently enrolled in another interventional clinical trial or have participated in a trial within the 3 months prior to screening, will be excluded.
2. Participant has history of prior hormonal therapy use (eg, androgenic steroids, gonadotropin-releasing hormone agonists and antagonists) within the past 6 months from the screening visit.
3. Participant on exam has any of the following: vas not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intra-scrotal mass that would make the participant not suitable for the study.
4. Participant has a known allergic reaction to polyethylene glycol containing products or has had a prior severe allergic response to injectable or implantable devices.
5. Participant has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution of an acute infection.
6. Participant has current coagulopathy or other bleeding disorders.
7. Participant currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (eg, anabolic steroids, chemotherapy, alpha blocker).
8. Participant had a previous successful or unsuccessful vasectomy or vasectomy reversal.
9. Participant has any clinically significant abnormal findings or other findings identified by the investigator that would exclude the participant.
10. Participant is without access to telephone and/or ability to gain technology access.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2025
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Actual
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Date of last participant enrolment
Anticipated
1/08/2026
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Actual
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Date of last data collection
Anticipated
1/08/2028
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
27264
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Wollongong Private Hospital - Wollongong
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Recruitment hospital [2]
27265
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St Andrew's War Memorial Hospital - Brisbane
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Recruitment postcode(s) [1]
43351
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2500 - Wollongong
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Recruitment postcode(s) [2]
43352
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4000 - Brisbane
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Funding & Sponsors
Funding source category [1]
317687
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Commercial sector/Industry
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Name [1]
317687
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Contraline Australia Pty Ltd.
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Address [1]
317687
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Country [1]
317687
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Contraline Australia Pty Ltd.
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Address
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Country
Australia
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Secondary sponsor category [1]
320015
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None
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Name [1]
320015
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Address [1]
320015
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Country [1]
320015
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316385
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UnitingCare Health Human Research Ethics Committee
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Ethics committee address [1]
316385
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http://unitingcarehealth.com.au/research-and-education/unitingcare-health-human-research-ethics-committee
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Ethics committee country [1]
316385
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Australia
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Date submitted for ethics approval [1]
316385
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29/10/2024
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Approval date [1]
316385
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10/06/2025
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Ethics approval number [1]
316385
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Ethics committee name [2]
316390
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Bellberry Human Research Ethics Committee G
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Ethics committee address [2]
316390
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https://bellberry.com.au/
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Ethics committee country [2]
316390
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Australia
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Date submitted for ethics approval [2]
316390
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06/11/2024
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Approval date [2]
316390
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10/12/2024
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Ethics approval number [2]
316390
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Summary
Brief summary
This study will test the safety and effectiveness of ADAM™ 2.0, a new contraceptive device for men, in a group of 30 healthy males aged 25 to 55 who are considering a vasectomy. Researchers believe that ADAM™ 2.0 can block sperm flow safely and could offer a reliable, non-hormonal, non-permanent alternative to traditional vasectomy. Participants will be closely monitored to assess how well the device works and to ensure their safety. The study aims to gather valuable information on the potential of ADAM™ 2.0 as a long-term contraceptive solution for men. The study hypothesis is that implanting a pre-formed, water-soluble hydrogel into the vas deferens will effectively block sperm flow into the ejaculate, thereby reducing sperm counts to near zero and preventing pregnancies.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Peter Chin
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Address
137730
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South Coast Urology, 91 Burelli St, Wollongong NSW 2500
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Country
137730
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Australia
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Phone
137730
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+61 2 42716644
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Fax
137730
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Email
137730
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[email protected]
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Contact person for public queries
Name
137731
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Viki Krkovski
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Address
137731
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South Coast Urology, 91 Burelli St, Wollongong NSW 2500
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Country
137731
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Australia
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Phone
137731
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+61 2 42716644
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Fax
137731
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Email
137731
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[email protected]
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Contact person for scientific queries
Name
137732
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Alex Pastuszak
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Address
137732
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Contraline Pty Ltd, 818 E Jefferson Street, Suite 201, Charlottesville, Virginia, 22902, USA
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Country
137732
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United States of America
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Phone
137732
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+1 415 412 2934
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Fax
137732
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Email
137732
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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