NLS-133 for Male Birth Control

Overseen By John K Amory, MD, MPH, MSc

Age: 18 - 65

Sex: Male

Trial Phase: Phase 2

Sponsor: Next Life Sciences

Must not be taking: Sex hormones, Anabolic steroids, Opioids, others

Disqualifiers: Erectile dysfunction, Infertility, Drug abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

NLS-133-CLIN001 is a Phase 2a study designed to assess the safety, tolerability, and effects of NLS-133 (combination of two FDA-approved agents) compared to an active control (FDA-approved pharmacologic agent) or placebo on semen volume and sperm count in 10 in healthy men. Participants will be randomized in a crossover design to receive a single dose of NLS-133, an active control or placebo either 90 or 180 minutes prior to collection of semen. Sperm parameters measured will be count, motility and morphology. A brief questionnaire will be completed by each subject during each treatment cycle that addresses orgasm and ejaculation quality. Safety monitoring will include adverse event reporting, laboratory assessments, and vital signs.

Are You a Good Fit for This Trial?

This trial is for healthy men interested in a non-hormonal 'on-demand' contraceptive. Participants should have normal semen volume and sperm count, and be willing to take a single dose of the study drug or placebo before providing semen samples.

Inclusion Criteria

Normal baseline sperm parameters (semen volume >1.4 cc, sperm concentration >15 million/ml, motility >40% and morphology >4%)

I don't have any major health issues that could affect my safety in the study.

Normal values on baseline hematology, blood chemistry and liver function tests and serum testosterone

Exclusion Criteria

I am currently on treatment for a serious infection.

I do not have active hepatitis B, C, HIV, or COVID-19.

History or evidence of erectile dysfunction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of NLS-133, an active control, or placebo 90 or 180 minutes prior to semen collection in a crossover design

6 weeks

Multiple visits for each treatment cycle

Washout

A 72-hour washout period between dosing cycles to ensure no carryover effects

72 hours between cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NLS-133

Trial Overview

The trial tests NLS-133 against an active control (another FDA-approved agent) and a placebo. It's designed to see how well NLS-133 works by comparing changes in semen volume and sperm parameters like count, motility, and morphology after taking it.

How Is the Trial Designed?

Group I: NLS-133 (combination of two FDA-approved drugs) Experimental Treatment 1 Intervention

Group II: Active Control Active Control 1 Intervention

generic alpha-1-adrenergic receptor antagonist

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Next Life Sciences

Lead Sponsor

Trials

1

Recruited

30+