NCT07393334

RecruitingPhase 2

Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Mal...

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Other study identifiers

Sponsor study identifier

NLS-133-CLIN001

Study Type

interventional

Estimated enrollment

10

Locations

1 country

Sites

1

Timeline

Study Start

December 2, 2025

Actual (reported)

Primary Completion

March 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

May 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 10 participants
Study completion date: May 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2, 2025
Actual (reported)
First Submitted
December 31, 2025
Actual (reported)
First Posted
February 6, 2026
Actual (reported)
Primary Completion
March 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: February 6, 2026
Status Verified: January 2026
Last Update Submitted: January 30, 2026

Conditions

Male Contraception Semen Volume Sperm Motility

Keywords

Effect of NLS-133 on semen volume and semen parameters

Outcome Measures

Primary Outcomes (2)

Semen volume (mL)
90 and 180 minutes for each treatment cycle
Sperm count (millions/mL)
Measurement of sperm count
90 and 180 minutes for each treatment cycle

Secondary Outcomes (1)

Sperm motility
90 and 180 after placebo, active-control or NLS-133 administration

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Active Control

ACTIVE COMPARATOR

generic alpha-1-adrenergic receptor antagonist

Drug: Active Comparator #1

NLS-133 (combination of two FDA-approved drugs)

EXPERIMENTAL

Drug: NLS-133

Interventions

NLS-133Drug

NLS-133 is the primary experimental arm of the study

NLS-133 (combination of two FDA-approved drugs)

PlaceboDrug

Double placebo arm of the study

Placebo

Eligibility Criteria

Age18 Years - 55 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male, age 18-55.
Normal physical examination and testicular volume \>15 cc

Sponsors & Collaborators

Next Life Sciences
Industrylead

Study Sites (1)

Population Center for Research in Human Reproduction and Departments of Medicine, University of Washington

Seattle, Washington, 98195, United States

RECRUITING

John K Amory, MD, MPH, MScCONTACT(206) 616-1727 jamory@uw.edu

Central Study Contacts

John K Amory, MD, MPH, MSc

CONTACT

(206) 616-1727 jamory@uw.edu

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 31, 2025

First Posted

February 6, 2026

Study Start

December 2, 2025

Actual (reported)

Primary Completion

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Active Comparator #1Drug

Active control arm of study

Also known as: Active control

Active Control

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

No significant medical history that would impact the safety of the study.

No current use of drugs that comprise NLS-133

Normal values on baseline hematology, blood chemistry and liver function tests and serum testosterone.

Normal baseline sperm parameters (semen volume \>1.4 cc, sperm concentration \>15 million/ml, motility \>40% and morphology \>4%).

Willing and able to comply with all study requirements and procedures.

You may not qualify if:

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.
Evidence of significant underlying disease (based on results of the physical exam and the routine labs).
Known infertility or hypogonadism.
Planned or anticipated use of any prohibited medications during participation in the study. These include use of sex hormones for treatment, testosterone, anabolic steroids, retinoic acid (e.g., Accutane®), vitamin A, other drugs known to inhibit spermatogenesis, opioids, cocaine, methamphetamine, and/or the consumption of \>4 alcoholic beverages daily.
Presence of moderate-to-severe pulmonary or cardiovascular disease
Known active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or COVID-19 infection.
History of malignancy within 5 years before the Screening Visit, except fully treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
Known active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals during the Screening period.
Any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation in the judgment of the investigator would make the participant inappropriate for entry into the study.
Participation in another investigational clinical trial within the last 30 days.
Participants who live in detention on court order or on regulatory action.
Related to sponsor or staff involved in the conduct of the study.

Contact the study team to confirm eligibility.

March 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

May 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07393334
Data provider: ClinicalTrials.gov
Source updated: 2026-02-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:45 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (3)

Placebo

Active Control

NLS-133 (combination of two FDA-approved drugs)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations