Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by University of Miami. The registered enrollment target is 60 participants.
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.
Interventions
- DRUG Natesto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-10-27 |
| Est. Completion | 2020-06-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03203681
The ClinicalTrials.gov registry entry for NCT03203681 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Natesto is the first listed.
NCT03203681 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.