Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive
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.
Timeline
- Start
- 2025-12-02
- Primary completion
- 2026-03
- Completion
- 2026-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guanfacine | Small molecule | — | Oral |
| Subject | Silodosin | Unknown | — | Oral |
Indications
No indication recorded.