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
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.
Description
The aim of study NLS-133-CLIN001is to determine the time frame NLS-133 (combination of two FDA-approved agents) affected ejaculation, semen volume and sperm count in young, normal men. NLS-133 responses will be compared to responses observed after oral placebo and active control (FDA-approved pharmacological agent) treatments. This is a randomized, double-blind, placebo-controlled, crossover (6-way) trial of 10 men who will receive oral capsules 90 and 180 minutes prior to semen collection by masturbation. There will be at least a 72 hour washout period between dosing cycles. Semen volume, if…
Eligibility
- Age range
- 18–55 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Male, age 18-55. 2. Normal physical examination and testicular volume \>15 cc 3. No significant medical history that would impact the safety of the study. 4. No current use of drugs that comprise NLS-133 5. Normal values on baseline hematology, blood chemistry and liver function tests and serum testosterone. 6. Normal baseline sperm parameters (semen volume \>1.4 cc, sperm concentration \>15 million/ml, motility \>40% and morphology \>4%). 7. Willing and able to comply with all study requirements and procedures. Exclusion Criteria: 1. History or evidence of erectile d…
Interventions
- DrugNLS-133
NLS-133 is the primary experimental arm of the study
- DrugPlacebo
Double placebo arm of the study
- DrugActive Comparator #1
Active control arm of study
Location
- Population Center for Research in Human Reproduction and Departments of Medicine, University of WashingtonSeattle, Washington