Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive (NCT07393334) | Clinical Trial Compass
RecruitingPhase 2
Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive
United States10 participantsStarted 2025-12-02
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexMALE
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Inclusion criteria
✓. Male, age 18-55.
✓. Normal physical examination and testicular volume \>15 cc
✓. No significant medical history that would impact the safety of the study.
✓. No current use of drugs that comprise NLS-133
✓. Normal values on baseline hematology, blood chemistry and liver function tests and serum testosterone.
✓. Normal baseline sperm parameters (semen volume \>1.4 cc, sperm concentration \>15 million/ml, motility \>40% and morphology \>4%).
✓. Willing and able to comply with all study requirements and procedures.
Exclusion criteria
✕. History or evidence of erectile dysfunction.
✕. Inability to produce semen samples in clinic setting.
✕. Significant chronic or acute medical illness.
What they're measuring
1
Semen volume (mL)
Timeframe: 90 and 180 minutes for each treatment cycle
2
Sperm count (millions/mL)
Timeframe: 90 and 180 minutes for each treatment cycle
. Previous or current ethanol or illicit drug abuse.
✕. Evidence of significant underlying disease (based on results of the physical exam and the routine labs).
✕. Known infertility or hypogonadism.
✕. Planned or anticipated use of any prohibited medications during participation in the study. These include use of sex hormones for treatment, testosterone, anabolic steroids, retinoic acid (e.g., Accutane®), vitamin A, other drugs known to inhibit spermatogenesis, opioids, cocaine, methamphetamine, and/or the consumption of \>4 alcoholic beverages daily.
✕. Presence of moderate-to-severe pulmonary or cardiovascular disease