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

NCT05134428 | Completed DMC

• 1 other identifier: ADM-012
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Male Contraception; Healthy Male Adults

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  The primary endpoint is the number of all treatment-emergent adverse events

  30 Days

Secondary Outcomes (3)

• Serious AEs

  30 Days

• Adverse Events of Interest

  2 years

• Azoospermia

  2 years

Study Arms (4)

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.

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.

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.

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.

Device: ADAM System

Interventions

ADAM System DEVICE

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.

ADAM Cohort 1; ADAM Cohort 2; ADAM Cohort 3; ADAM Cohort 4

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Contraline, Inc: lead

Study Sites (3)

South Coast Urology

Wollongong, New South Wales, 2500, Australia

Location

AndroUrology

Brisbane, Queensland, 4001, Australia

Location

Epworth HealthCare

East Melbourne, Victoria, 3002, Australia

Location

Study Officials

• Alex Pastuszak, MD, PhD

  Contraline, Inc

  STUDY DIRECTOR

• Nathan Lawrentschuk, MB, BS, PhD, FRACS

  Epworth Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: November 26, 2021
• Study Start: May 20, 2022
• Primary Completion: March 20, 2024
• Study Completion: March 8, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)