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NCT03203681 · ClinicalTrials.gov registry record · Phase 4
Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters
A Phase 4 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT03203681: Completed Phase 4 study, sponsored by University of Miami.
NCT03203681 is a Phase 4 study that has completed, run by University of Miami. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03203681, a Phase 4 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
Low testosterone affects more than 10% of men worldwide, with high incidence in the elderly.This will be a prospective case study. The investigators will identify men with hypogonadism in our clinic interested in Natesto for testosterone replacement therapy (TRT). Natesto is a relatively new form of testosterone replacement therapy that is delivered intranasal to men diagnosed with low testosterone. Current advantages to Natesto include ease of delivery and decreased risk of transference. Recently Natesto 4.5% (125 uL/nostril, 11.0mg testosterone/dose), three times a day (TID) dosing was shown to also increase serum testosterone while maintaining normal, though decreased, serum levels of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone(FSH). 40 participants will be enrolled and receive treatment with Natesto.The study will identify men with confirmed hypogonadism (testosterone (T) \<350 on 2 consecutive Testosterone samples collected greater than 1.5 hours apart between 6am and 10am with demonstrated symptoms of hypogonadism). Participants with a history of prostate cancer, testis cancer, azoospermia, or genetic cause of hypogonadism will be excluded.
Primary Outcome
Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw
Interventions
- DRUG Natesto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-10-27 |
| Est. Completion | 2020-06-01 |
| Phase | Phase 4 |
What the finished NCT03203681 record still lists
NCT03203681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Natesto is the first listed.
NCT03203681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03203681 about?
NCT03203681 is a clinical study titled "Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters". Low testosterone affects more than 10% of men worldwide, with high incidence in the elderly.This will be a prospective case study. The investigators will identify men with hypogonadism in our clinic interested in Natesto for testosterone replacement therapy (TRT). Natesto is a relatively new form of...
What is the current status of trial NCT03203681?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2017-10-27. Estimated completion is 2020-06-01.
What interventions are being tested in trial NCT03203681?
The interventions under investigation include: Natesto (DRUG).
Who is sponsoring clinical trial NCT03203681?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03203681's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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