Phase 4
N=60
Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters
Hypogonadism, Male
Bottom Line
View on ClinicalTrials.gov: NCT03203681 ↗Enrolled (actual)
60
Serious AEs
6.7%
Results posted
Aug 2021
Primary outcome: Primary: Change in Testosterone Levels From Baseline to 27 Weeks — 652 ng/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Natesto (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Testosterone Levels From Baseline to 27 Weeks |
652 | — |
| PRIMARY Change in Estradiol Levels From Baseline to 27 Weeks |
21.6 | — |
| PRIMARY Change in Gonadotropin Levels From Baseline to 27 Weeks |
3.0; 2.6 | — |
| PRIMARY Number of Participants With an Increase in SF-36 QOL Scores From Baseline |
32 | — |
| PRIMARY Change in Sperm Counts From Baseline to 27 Weeks |
33.9 | — |
| PRIMARY Incidence of Adverse Events |
1; 3; 5; 1; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
- Male between 18 and 55 years of age, inclusive, with documented onset of hypogonadism prior to age 55.
- Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
- Serum total testosterone 19 points.
- Body mass index (BMI) ≥ 30 kg/m2.
- Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
- Baseline hemoglobin 16 g/dL
- Hematocrit 54%
- Serum transaminases > 2.5 times upper limit of normal
- Serum bilirubin > 2.0 mg/dL
- Creatinine > 2.0 mg/dL f. Prostate-Specific Antigen (PSA) > 2 ng/mL
- History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
- History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
- History of stroke or myocardial infarction within the past 5 years.
- History of, or current or suspected, prostate or breast cancer.
- History of diagnosed, severe, untreated, obstructive sleep apnea.
- History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.
- Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.
- Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
- Inability to understand and provide written informed consent for the study.
- Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Natesto.
Data sourced from ClinicalTrials.gov (NCT03203681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.