40 Participants NeededMy employer runs this trial

Male Contraceptive System for Healthy Adult Males

Recruiting at 3 trial locations
DW
Overseen ByDarlene Walley R Chief Executive Officer, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new male contraceptive system, the Plan A Male Contraceptive System, which temporarily blocks sperm by targeting the vas deferens (the tube that carries sperm). The researchers aim to determine if the system is safe and effective in preventing pregnancy and if it can be reversed to allow sperm to pass through again. One group will undergo only the blocking procedure, while another group will also have a reversal procedure. The trial seeks healthy men considering a vasectomy as a long-term birth control option. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants, offering them a chance to contribute to innovative contraceptive solutions.

What prior data suggests that the Plan A Male Contraceptive System is safe for use in occluding and reversing the vas deferens?

Research has shown that previous studies on male birth control methods have found only minor side effects. For instance, one study with healthy men found the treatment mostly well-received, with only a few men experiencing mild issues like fatigue, acne, or headaches. Another study examined a non-hormonal method, which also showed no major side effects. These findings suggest that the Plan A Male Contraceptive System, which temporarily blocks sperm, might be safe for most users. However, individual experiences can vary with any treatment.12345

Why are researchers excited about this trial's treatment?

Researchers are excited about the Plan A Male Contraceptive System because it represents a non-hormonal approach to male contraception, setting it apart from traditional methods like condoms and vasectomies. Unlike vasectomies, which are often permanent, this system includes a reversible occlusion procedure, allowing men more flexibility in family planning. The system also avoids the side effects associated with hormonal male contraceptives, offering a potentially safer and less invasive option. This innovative approach could significantly expand contraceptive choices for men, providing a more controlled and reversible solution.

What evidence suggests that the Plan A Male Contraceptive System is effective for male contraception?

Research has shown that the Plan A Male Contraceptive System blocks the tube carrying sperm from the testicles, preventing sperm from mixing with semen and acting as a contraceptive. In this trial, participants in Group 1 will undergo the occlusion procedure, while those in Group 2 will have both the occlusion and reversal procedures. Early studies indicate that this blockage can be undone, allowing sperm to flow normally again, which means fertility can be restored if desired. This system offers a temporary and reversible way to prevent pregnancy. While more research is needed to confirm its long-term effectiveness, it appears promising for those seeking a non-permanent birth control option.

Who Is on the Research Team?

HZ

Homi Zargar, MD

Principal Investigator

Western Urology

Are You a Good Fit for This Trial?

This trial is for healthy men aged 25 to 65 who are considering a vasectomy as long-term birth control, have normal semen tests, a BMI under 31, and live near the study site. Participants must be in good health and agree to use other contraception during the study.

Inclusion Criteria

I live near the trial site or can provide semen samples at the site or lab.
My BMI is less than 31 kg/m2.
I agree to use birth control until the planned vasectomy.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Occlusion Procedure

Participants undergo the occlusion procedure to block the passage of sperm

1 day
1 visit (in-person)

Follow-up (Post-Occlusion)

Participants are monitored for azoospermia for up to 6 months post occlusion procedure

6 months
Monthly visits (in-person)

Reversal Procedure

Participants in Group 2 undergo the reversal procedure to restore sperm passage

1 day
1 visit (in-person)

Follow-up (Post-Reversal)

Participants are monitored for return to baseline semen levels for up to 3 months post reversal procedure

3 months
Monthly visits (in-person)

Final Follow-up

Participants are monitored for safety and effectiveness after all procedures

1 month
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Plan A Male Contraceptive System

Trial Overview

The study is testing a new male contraceptive device that temporarily blocks sperm by occluding the vas deferens. The system can later be reversed so sperm can pass again. All participants receive this intervention.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Group 2: Reversal ProcedureExperimental Treatment1 Intervention
Group II: Group 1: Occlusion ProcedureExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Next Life Sciences

Lead Sponsor

Trials
1
Recruited
30+

Clinico Pty Ltd

Collaborator

Citations

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