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

ConditionsMale ContraceptionSemen VolumeSperm Motility
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • NLS-133

    Drug

    NLS-133 is the primary experimental arm of the study

  • Placebo

    Drug

    Double placebo arm of the study

  • Active Comparator #1

    Drug

    Active control arm of study

Treatment groups

10 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Active ControlActive comparator 1 intervention
Group C: NLS-133 (combination of two FDA-approved drugs)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Semen volume (mL)

Time frame
90 and 180 minutes for each treatment cycle
2

Sperm count (millions/mL)

Measurement of sperm count

Time frame
90 and 180 minutes for each treatment cycle

Secondary outcomes

1

Sperm motility

Total percentage of sperm that are actively swimming

Time frame
90 and 180 after placebo, active-control or NLS-133 administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Next Life Sciences

Lead sponsor

Source ClinicalTrials.gov
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