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NCT06993155 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function
A Phase 2 study of Semen Quality, sponsored by ReproNovo Aps.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 4
- Study locations
NCT06993155: Recruiting Phase 2 study of Semen Quality, sponsored by ReproNovo Aps.
NCT06993155 is a Phase 2 study of Semen Quality that is actively recruiting participants, run by ReproNovo Aps. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06993155, a Phase 2 study of Semen Quality, is actively recruiting participants, sponsored by ReproNovo Aps.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 4
- Study locations
Study Summary
The goal of this clinical trial is to evaluate three doses of the drug leflutrozole on improvement of semen quality in men. It will also study the safety of leflutrozole. The main questions it aims to answer are: * Does leflutrozole improve semen quality? * What medical problems do participants experience when taking leflutrozole? Researchers will compare leflutrozole to a placebo (a look-alike substance that contains no drug). Participants will: * Take leflutrozole or a placebo orally once a week for 16 weeks. * Visit the clinic every 4 weeks for checkups and tests. * Provide semen samples to measure changes in semen quality. * Have their blood tested to measure hormone levels and ensure safety. * Be monitored for any side effects.
Primary Outcome
Total motile sperm count will be assessed through semen analysis conducted at specialized andrology laboratories.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Leflutrozole, Dose 1
- DRUG Leflutrozole, Dose 2
- DRUG Leflutrozole, Dose 3
Study Locations (4)
California
- ReproNovo Investigational Site - North Hollywood
- ReproNovo Investigational Site - Pomona
New York
- ReproNovo Investigational Site - Garden City
Ohio
- ReproNovo Investigational Site - Middleburg Heights
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-06-27 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What NCT06993155 shows while recruiting
NCT06993155 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Semen Quality appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06993155 reports a single indexed study location in California, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT06993155 about?
NCT06993155 is a clinical study titled "A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function". The goal of this clinical trial is to evaluate three doses of the drug leflutrozole on improvement of semen quality in men. It will also study the safety of leflutrozole. The main questions it aims to answer are: * Does leflutrozole improve semen quality? * What medical problems do participants ex...
What is the current status of trial NCT06993155?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2025-06-27. Estimated completion is 2026-11.
What conditions does trial NCT06993155 study?
This clinical trial studies the following conditions: Semen Quality.
What interventions are being tested in trial NCT06993155?
The interventions under investigation include: Placebo (DRUG), Leflutrozole, Dose 1 (DRUG), Leflutrozole, Dose 2 (DRUG), Leflutrozole, Dose 3 (DRUG).
Who is sponsoring clinical trial NCT06993155?
This trial is sponsored by ReproNovo Aps, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06993155 being conducted?
This trial has 4 study locations across California, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06993155's enrollment target sits among peer trials
200 304th of 2000 higher than 1,653 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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