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RECRUITING
NCT07393334
PHASE2

Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive

Sponsor: Next Life Sciences

View on ClinicalTrials.gov

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

DRUG

NLS-133

NLS-133 is the primary experimental arm of the study

DRUG

Placebo

Double placebo arm of the study

DRUG

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