Actively Recruiting
Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive
Led by Next Life Sciences · Updated on 2026-02-06
10
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, age 18-55
- Normal physical examination and testicular volume greater than 15 cc
- No significant medical history that would affect study safety
- Not currently using drugs that make up NLS-133
- Normal baseline blood tests including hematology, chemistry, liver function, and serum testosterone
- Normal baseline sperm parameters: semen volume over 1.4 cc, sperm concentration over 15 million/ml, motility over 40%, morphology over 4%
- Willing and able to follow all study procedures and requirements
You will not qualify if you...
- History or evidence of erectile dysfunction
- Unable to produce semen samples in clinic
- Significant chronic or acute medical illness
- Past or current alcohol or illicit drug abuse
- Evidence of significant underlying disease from physical exam or labs
- Known infertility or hypogonadism
- Planned or expected use of prohibited medications including sex hormones, testosterone, anabolic steroids, retinoic acid, vitamin A, drugs that inhibit sperm production, opioids, cocaine, methamphetamine, or drinking more than 4 alcoholic drinks daily
- Moderate to severe lung or heart disease
- Known active hepatitis B, hepatitis C, HIV, or COVID-19 infection
- History of cancer within 5 years except treated non-metastatic skin cancer
- Active chronic or acute infection needing systemic antibiotics or antivirals during screening
- Any medical or psychiatric condition or lab abnormality increasing study risk as judged by investigator
- Participation in another clinical trial within 30 days
- Living in detention by court order or regulatory action
- Related to study sponsor or staff involved in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Population Center for Research in Human Reproduction and Departments of Medicine, University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
J
John K Amory, MD, MPH, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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