Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-55
SponsorNext Life Sciences
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
History or evidence of erectile dysfunction.
Inability to produce semen samples in clinic setting.
Significant chronic or acute medical illness.
Previous or current ethanol or illicit drug abuse.
Trial design
Treatments tested in this trial
- NLS-133
- Placebo
- Active Comparator #1
Treatment groups
10 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov