Male ContraceptionNCT05134428
A First in Human Study, Evaluating the Safety and Efficacy of ADAM™ 1.0
A study testing ADAM System in people with Male Contraception and Healthy Male Adults, run by Contraline, Inc at 3 sites in Australia.
Trial summary
This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 25 healthy males at 3 sites. This is a prospective, non-randomized, open label interventional trial. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Contraception, Healthy Male Adults
- What is being tested?
- ADAM System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesAustralia
- Study dates
- 20 May 2022to 8 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is male
- Subject is 25 to 65 years of age
- 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
- Subject is suitable to undergo a vasectomy as a long-term form of contraception
- Subject is legally competent
- 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
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- 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
- Subject is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study.
- 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)
Who cannot join
- Potential subjects will be excluded if ANY of the following criteria apply:
- Subject is participating in another interventional clinical trial currently or within the past 3 months from the time of screening
- Subject has history of prior hormonal therapy use (e.g., androgenic steroids, GnRH agonists and antagonists) within the past 6 months
- 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
- Subject has allergic reaction to polyethylene glycol (PEG) containing products or has had a prior severe allergic response to injectable or implantable devices
- 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
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- Subject has current coagulopathy or other bleeding disorders
- 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)
- Subject had a previous successful or unsuccessful vasectomy or vasectomy reversal
- Subject has any clinically significant abnormal findings or other findings identified by Investigator that would exclude the subject.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
AndroUrology
Brisbane, Queensland, 4001
Epworth HealthCare
East Melbourne, Victoria, 3002
South Coast Urology
Wollongong, New South Wales, 2500
About this study
Official title: Open-label, Dose Ranging, Multi-Centre, Prospective First in Human Study to Assess the Safety of the ADAM System
This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 25 healthy males at 3 sites. This is a prospective, non-randomized, open label interventional trial.
Read the detailed description
The ADAM System consists of the ADAM Hydrogel and the ADAM Injector. The ADAM Hydrogel is a proprietary, injectable, co-polymer hydrogel designed to provide long-lasting, non-permanent vasal occlusion for men. The ADAM Injector automates the dose and speed at which the ADAM Hydrogel is delivered into the vas deferens. The vas deferens may be accessed using a minimally invasive no-scalpel technique. Once inserted into the lumen of the vas deferens, the hydrogel prevents sperm transport from the epididymis into the ejaculate.
Subjects will be followed up to 24 months or until semen analysis is ≥ 15 million sperm/mLA second semen analysis may be required to confirm sperm concentration, this is to be requested at the discretion of the study investigator, the second sample must be collected ≥2 days and ≤10 days of the first).
The 25 subjects will be enrolled as follows:
A minimum of 3 and up to 13 in each cohort. The Cohorts will enroll in parallel.
The DSMB will meet at various timepoints during the study to review the safety data from the subjects (up to the 30-day post implant visit), e.g. after the first 4-5 subjects in any given cohort. Appropriate action will be taken if any related event is observed.
Pre-procedure, the subject will provide two separate semen samples for lab analysis, the results of which will be averaged. The duration between collection of both specimens will be ≥2 days and ≤7 days. This will determine baseline sperm count and eligibility for enrolment.
All subjects who demonstrate azoospermia or virtual azoospermia post-procedure will be followed until the semen analysis at any designated timepoint/visit demonstrates a sperm concentration ≥ 15 million sperm/mLthe lower 5% reference limit according to the WHO Laboratory Manual for the Examination and Processing of Human Semen). The subject may subsequently undergo a second lab semen analysis within 2-10 days to confirm the sperm concentration (decided at the discretion of the study investigator). If the subject's sperm concentration is still not conclusive after the second analysis, they will remain on trial until conclusive results are achieved. The subject's participation in the study will end once their semen analysis demonstrates ≥ 15 million sperm/mL or at 24 months after ADAM implantation, whichever is sooner. Subjects who do not achieve azoospermia by month 12 will be exited from the study. For clarity, subjects will remain in the study for a minimum of 12 months whether or not they achieve azoospermia or until resolution of any adverse event. Subjects whose participation in the study ends will be offered a vasectomy.
An alternative form of contraception will be required for the duration of the study regardless of whether the subject demonstrates azoospermia during the course of the study.
Lab Samples: All lab samples will be destroyed as per the local lab standard policy. The samples will not be retained for any further analysis or research.
- Conditions
- Male Contraception, Healthy Male Adults
- Being tested
- ADAM System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAM SystemDevice
The ADAM System consists of an injectable hydrogel and delivery apparatus that is intended to provide long-lasting, non-permanent vasal occlusion for men, resulting in azoospermia. ADAM is designed to be inserted into the vasa deferentia through a minimally invasive procedure, similar to the no-scalpel vasectomy.
| Study group | Role | What they receive |
|---|---|---|
| ADAM Cohort 1 | Experimental | The first 5 subjects will be reviewed for safety by a Data Safety Monitoring Board (DSMB) at 30 days post-implantation. The 5 subjects will then be followed up to 24 months or until their semen analyses is ≥ 15 million sperm/mL. Receives: Device: ADAM System |
| ADAM Cohort 2 | Experimental | An additional 13 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL. Receives: Device: ADAM System |
| ADAM Cohort 3 | Experimental | An additional 4 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL. Receives: Device: ADAM System |
| ADAM Cohort 4 | Experimental | An additional 3 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL. Receives: Device: ADAM System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The primary endpoint is the number of all treatment-emergent adverse events
Measured: 30 Days
Secondary outcomes (3)
Serious AEs
Number and percentage of subjects experiencing procedure and device-related serious adverse events at 30 days
Measured: 30 Days
Adverse Events of Interest
Number and percentage of subjects experiencing an adverse event of interest during the study
Measured: 2 years
Azoospermia
Percentage of subjects achieving absolute azoospermia, defined as a zero sperm count, and percentage of subjects achieving virtual azoospermia, defined as a sperm count of ≤100,000 per mL and 0% motility
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start20 May 2022
- Primary completion20 Mar 2024
- Study completion8 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contraline, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Pastuszak, MD, PhD, Study director, Contraline, IncNathan Lawrentschuk, MB, BS, PhD, FRACS, Principal investigator, Epworth Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134428
- Sponsor's protocol ID
- ADM-012
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2021
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang C, Meriggiola MC, Amory JK, Barratt CLR, Behre HM, Bremner WJ, Ferlin A, Honig S, Kopa Z, Lo K, Nieschlag E, Page ST, Sandlow J, Sitruk-Ware R, Swerdloff RS, Wu FCW, Goulis DG. Practice and development of male contraception: European Academy of Andrology and American Society of Andrology guidelines. Andrology. 2024 Oct;12(7):1470-1500. doi: 10.1111/andr.13525. Epub 2023 Sep 20.
PubMed 37727884
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Dose Ranging, Multi-Centre, Prospective First in Human Study to Assess the Safety of the ADAM System
- ClinicalTrials.gov ID
- NCT05134428
- Acronym / sponsor ID
- ADM-012
- Conditions
- Male Contraception, Healthy Male Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Contraline, IncIndustry (pharma, biotech, devices)
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 8 Mar 2026 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 25 healthy males at 3 sites. This is a prospective, non-randomized, open label interventional trial.
Detailed description
The ADAM System consists of the ADAM Hydrogel and the ADAM Injector. The ADAM Hydrogel is a proprietary, injectable, co-polymer hydrogel designed to provide long-lasting, non-permanent vasal occlusion for men. The ADAM Injector automates the dose and speed at which the ADAM Hydrogel is delivered into the vas deferens. The vas deferens may be accessed using a minimally invasive no-scalpel technique. Once inserted into the lumen of the vas deferens, the hydrogel prevents sperm transport from the epididymis into the ejaculate.
Subjects will be followed up to 24 months or until semen analysis is ≥ 15 million sperm/mLA second semen analysis may be required to confirm sperm concentration, this is to be requested at the discretion of the study investigator, the second sample must be collected ≥2 days and ≤10 days of the first).
The 25 subjects will be enrolled as follows:
A minimum of 3 and up to 13 in each cohort. The Cohorts will enroll in parallel.
The DSMB will meet at various timepoints during the study to review the safety data from the subjects (up to the 30-day post implant visit), e.g. after the first 4-5 subjects in any given cohort. Appropriate action will be taken if any related event is observed.
Pre-procedure, the subject will provide two separate semen samples for lab analysis, the results of which will be averaged. The duration between collection of both specimens will be ≥2 days and ≤7 days. This will determine baseline sperm count and eligibility for enrolment.
All subjects who demonstrate azoospermia or virtual azoospermia post-procedure will be followed until the semen analysis at any designated timepoint/visit demonstrates a sperm concentration ≥ 15 million sperm/mLthe lower 5% reference limit according to the WHO Laboratory Manual for the Examination and Processing of Human Semen). The subject may subsequently undergo a second lab semen analysis within 2-10 days to confirm the sperm concentration (decided at the discretion of the study investigator). If the subject's sperm concentration is still not conclusive after the second analysis, they will remain on trial until conclusive results are achieved. The subject's participation in the study will end once their semen analysis demonstrates ≥ 15 million sperm/mL or at 24 months after ADAM implantation, whichever is sooner. Subjects who do not achieve azoospermia by month 12 will be exited from the study. For clarity, subjects will remain in the study for a minimum of 12 months whether or not they achieve azoospermia or until resolution of any adverse event. Subjects whose participation in the study ends will be offered a vasectomy.
An alternative form of contraception will be required for the duration of the study regardless of whether the subject demonstrates azoospermia during the course of the study.
Lab Samples: All lab samples will be destroyed as per the local lab standard policy. The samples will not be retained for any further analysis or research.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADAM Cohort 1 | Experimental | Device: ADAM SystemThe first 5 subjects will be reviewed for safety by a Data Safety Monitoring Board (DSMB) at 30 days post-implantation. The 5 subjects will then be followed up to 24 months or until their semen analyses is ≥ 15 million sperm/mL. |
| ADAM Cohort 2 | Experimental | Device: ADAM SystemAn additional 13 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL. |
| ADAM Cohort 3 | Experimental | Device: ADAM SystemAn additional 4 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL. |
| ADAM Cohort 4 | Experimental | Device: ADAM SystemAn additional 3 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is ≥ 15 million sperm/mL. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject is male
- Subject is 25 to 65 years of age
- 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
- Subject is suitable to undergo a vasectomy as a long-term form of contraception
- Subject is legally competent
Key exclusion criteria (10 listed)
- Potential subjects will be excluded if ANY of the following criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAM SystemThe ADAM System consists of an injectable hydrogel and delivery apparatus that is intended to provide long-lasting, non-permanent vasal occlusion for men, resulting in azoospermia. ADAM is designed to be inserted into the vasa deferentia through a minimally invasive procedure, similar to the no-scalpel vasectomy. | Device | ADAM Cohort 1, ADAM Cohort 2, ADAM Cohort 3, ADAM Cohort 4 |
Primary outcome
Adverse Events
Time frame: 30 Days
The primary endpoint is the number of all treatment-emergent adverse events
3 secondary outcomes
Serious AEs
Time frame: 30 Days
Adverse Events of Interest
Time frame: 2 years
Azoospermia
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 37727884Wang C, Meriggiola MC, Amory JK, Barratt CLR, Behre HM, Bremner WJ, Ferlin A, Honig S, Kopa Z, Lo K, Nieschlag E, Page ST, Sandlow J, Sitruk-Ware R, Swerdloff RS, Wu FCW, Goulis DG. Practice and development of male contraception: European Academy of Andrology and American Society of Andrology guidelines. Andrology. 2024 Oct;12(7):1470-1500. doi: 10.1111/andr.13525. Epub 2023 Sep 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Pastuszak, MD, PhD study director
Contraline, Inc
Nathan Lawrentschuk, MB, BS, PhD, FRACS principal investigator
Epworth Healthcare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAM System in people with Male Contraception and Healthy Male Adults, run by Contraline, Inc at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.