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Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive
Sponsor: Next Life Sciences
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.
Official title: Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive, on Semen Volume and Sperm Count in Normal Men: A Double-Blind, Placebo-Controlled Trial
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2025-12-02
Completion Date
2026-05
Last Updated
2026-02-06
Healthy Volunteers
Yes
Interventions
NLS-133
NLS-133 is the primary experimental arm of the study
Placebo
Double placebo arm of the study
Active Comparator #1
Active control arm of study
Locations (1)
Population Center for Research in Human Reproduction and Departments of Medicine, University of Washington
Seattle, Washington, United States