BridgeMD
New treatment option for Male Contraception
Official title Effects of NLS-133, a Potential Non-Hormonal "On-Demand" Male Contraceptive
ClinicalTrials.gov ID: NCT07393334
What this study is testing
What is NLS-133?
NLS-133 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for male contraception.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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
- Normal values on baseline hematology, blood chemistry and liver function tests and serum testosterone.
You likely can't join 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.
See the full eligibility criteria
- 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
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.